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The Locking Pediatric Osteotomy Plate system

EUDAMEDFDA UDI

Class I (EU MDR)

Ref GIN-FCP100Model POINT-TO-POINT FORCEPSRef POP-OB45-20Model LOCKING SCREWRef POP-OB35-36Ref POP-OB27-40Ref POP-CB-40Model BLADERef POP-OB35-44Ref POP-GWR120-PKG2Model GUIDE WIRERef POP-LS35-16Ref POP-OB45-12Ref POP-LS35-40Ref POP-OB35-48Ref POP-LS27-18Ref POP-M3IModel ConnectorRef POP-GWR128-PKG6Model DEROTATION PINRef POP-CB-45Ref POP-OB35-12Ref POP-IVL-140Model PLATERef POP-LS27-20Ref POP-OB27-60Ref POP-AVR-100Ref POP-LS45-14Ref POP-AB-50Ref POP-OB27-26Ref POP-IB-25Ref POP-IVR-090Ref POP-LS45-24Ref POP-LS27-12Ref POP-CVR-090Ref POP-IB-45Ref POP-IVR-110Ref POP-AB-70Ref POP-CVL-130Ref POP-CB-35Ref POP-OB45-44Ref POP-LS45-16Ref POP-OB45-56Ref POP-OB27-16Ref POP-AB-40Ref POP-DCS135Model CORTICAL DRILLRef POP-AB-60Ref POP-HVL-120Ref POP-CB-60Ref POP-DCS127Ref POP-OB35-24Ref POP-LS35-28Ref POP-LS35-36Ref POP-OB45-24Ref POP-LS27-28Ref POP-LS45-22Ref POP-OB45-18Ref POP-OB35-16Ref POP-AVL-140Ref POP-M4CRef POP-OB35-14Ref POP-AVR-090Ref POP-LS27-36Ref POP-GWR120Ref POP-CB-30Ref POP-LS35-22Ref POP-OB45-26Ref POP-HVR-090Ref POP-LS27-14Ref POP-OB45-32Ref POP-OB45-28Ref POP-LS45-40Ref POP-IVL-130Ref POP-LS27-24Ref POP-LS35-20Ref POP-GWR128Ref POP-IB-30Ref POP-OB35-56Ref POP-OB45-48Ref POP-OB35-52Ref POP-OB35-32Ref POP-LS45-12Ref POP-OB27-56Ref POP-OB45-52Ref POP-OB27-52Ref POP-OB27-44Ref POP-HVL-130Ref POP-IB-40Ref POP-LS45-28Ref POP-HVR-110

by OrthoPediatrics Canada ULC

Identity

Trade Name
The Locking Pediatric Osteotomy Plate system EUDAMED
The Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Implantable orthopaedic/craniofacial device connection screw FDA UDI
Femoral fixation plate/blade FDA UDI
Bone holding forceps FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Device Name
Locking Screw, Ø4.5 X 40mm FDA UDI
Locking Screw, Ø4.5 X 24mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 32mm FDA UDI
LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 2 FDA UDI
LOLLIPOP DEROTATION PIN Ø2.8 FDA UDI
Locking Screw, Ø4.5 X 14mm FDA UDI
M4 Connector For Child FDA UDI
Locking Screw, Ø2.7 X 24mm FDA UDI
BLADE, CHILD 60mm FDA UDI
Locking Screw, Ø4.5 X 22mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 24mm FDA UDI
Locking Screw, Ø3.5 X 22mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 48mm FDA UDI
Blade, Infant 25mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 26mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 60mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 48mm FDA UDI
Varus Plate, Infant 110° FDA UDI
Locking Screw, Ø3.5 X 36mm FDA UDI
Blade, Infant 30mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 14mm FDA UDI
POINT-TO-POINT FORCEPS FDA UDI
Polyaxial Compression Screw, Ø2.7 X 56mm FDA UDI
Locking Screw, Ø4.5 X 16mm FDA UDI
Locking Screw, Ø2.7 X 18mm FDA UDI
BLADE, INFANT 45mm FDA UDI
Blade, Adolescent 60mm FDA UDI
Valgus Plate, Adolescent 140° FDA UDI
Valgus Plate, Child 130° FDA UDI
Blade, Adolescent 70mm FDA UDI
LOLLIPOP GUIDE WIRE Ø2.0 x 254mm FDA UDI
Ø2.5mm CORTICAL DRILL FOR Ø3.5mm SCREWS FDA UDI
Valgus Plate, HD Adolescent 130° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 16mm FDA UDI
Varus Plate, Child 90° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 32mm FDA UDI
Blade, Child 45mm FDA UDI
Blade, Adolescent 40mm FDA UDI
Varus Plate, Adolescent 90° FDA UDI
Locking Screw, Ø2.7 X 14mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 36mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 12mm FDA UDI
Locking Screw, Ø4.5 X 28mm FDA UDI
Valgus Plate, HD Adolescent 120° FDA UDI
Varus Plate, Adolescent 100° FDA UDI
Locking Screw, Ø2.7 X 36mm FDA UDI
Locking Screw, Ø4.5 X 12mm FDA UDI
Blade, Adolescent 50mm FDA UDI
Locking Screw, Ø2.7 X 20mm FDA UDI
Blade, Child 30mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 16mm FDA UDI
Locking Screw, Ø3.5 X 20mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 26mm FDA UDI
Varus Plate, HD Adolescent 110° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 44mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 44mm FDA UDI
Varus Plate, Infant 90° FDA UDI
LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 6 FDA UDI
Polyaxial Compression Screw, Ø4.5 X 56mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 52mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 12mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 24mm FDA UDI
BLADE, INFANT 40mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 52mm FDA UDI
Locking Screw, Ø2.7 X 12mm FDA UDI
Blade, Child 40mm FDA UDI
Ø2.0mm CORTICAL DRILL FOR Ø2.7mm SCREWS FDA UDI
Locking Screw, Ø3.5 X 28mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 20mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 56mm FDA UDI
Valgus Plate, Infant 130° FDA UDI
Polyaxial Compression Screw, Ø4.5 X 18mm FDA UDI
Locking Screw, Ø3.5 X 40mm FDA UDI
M3 Connector For Infant FDA UDI
Polyaxial Compression Screw, Ø2.7 X 40mm FDA UDI
Locking Screw, Ø2.7 X 28mm FDA UDI
Locking Screw, Ø3.5 X 16mm FDA UDI
Varus Plate, HD Adolescent 90° FDA UDI
Polyaxial Compression Screw, Ø4.5 X 28mm FDA UDI
Valgus Plate, Infant 140° FDA UDI
Polyaxial Compression Screw, Ø2.7 X 52mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 44mm FDA UDI
Blade, Child 35mm FDA UDI
Model / Reference
POINT-TO-POINT FORCEPS EUDAMED
GIN-FCP100 EUDAMEDFDA UDI
POP-LS45-40 EUDAMEDFDA UDI
POP-LS45-24 EUDAMEDFDA UDI
POP-OB45-32 EUDAMEDFDA UDI
POP-GWR120-PKG2 EUDAMEDFDA UDI
POP-GWR128 EUDAMEDFDA UDI
POP-LS45-14 EUDAMEDFDA UDI
POP-M4C EUDAMEDFDA UDI
POP-LS27-24 EUDAMEDFDA UDI
POP-CB-60 EUDAMEDFDA UDI
POP-LS45-22 EUDAMEDFDA UDI
POP-OB45-24 EUDAMEDFDA UDI
POP-LS35-22 EUDAMEDFDA UDI
POP-OB35-48 EUDAMEDFDA UDI
POP-IB-25 EUDAMEDFDA UDI
POP-OB45-26 EUDAMEDFDA UDI
POP-OB27-60 EUDAMEDFDA UDI
POP-OB45-48 EUDAMEDFDA UDI
POP-IVR-110 EUDAMEDFDA UDI
POP-LS35-36 EUDAMEDFDA UDI
POP-IB-30 EUDAMEDFDA UDI
POP-OB35-14 EUDAMEDFDA UDI
POP-OB27-56 EUDAMEDFDA UDI
POP-LS45-16 EUDAMEDFDA UDI
POP-LS27-18 EUDAMEDFDA UDI
POP-IB-45 EUDAMEDFDA UDI
POP-AB-60 EUDAMEDFDA UDI
POP-AVL-140 EUDAMEDFDA UDI
POP-CVL-130 EUDAMEDFDA UDI
POP-GWR120 EUDAMEDFDA UDI
POP-DCS135 EUDAMEDFDA UDI
POP-HVL-130 EUDAMEDFDA UDI
POP-OB35-16 EUDAMEDFDA UDI
POP-CVR-090 EUDAMEDFDA UDI
POP-OB35-32 EUDAMEDFDA UDI
POP-CB-45 EUDAMEDFDA UDI
POP-AB-40 EUDAMEDFDA UDI
POP-AVR-090 EUDAMEDFDA UDI
POP-LS27-14 EUDAMEDFDA UDI
POP-OB35-36 EUDAMEDFDA UDI
POP-OB45-12 EUDAMEDFDA UDI
POP-LS45-28 EUDAMEDFDA UDI
POP-HVL-120 EUDAMEDFDA UDI
POP-AVR-100 EUDAMEDFDA UDI
POP-LS27-36 EUDAMEDFDA UDI
POP-LS45-12 EUDAMEDFDA UDI
POP-AB-50 EUDAMEDFDA UDI
POP-LS27-20 EUDAMEDFDA UDI
POP-CB-30 EUDAMEDFDA UDI
POP-OB27-16 EUDAMEDFDA UDI
POP-LS35-20 EUDAMEDFDA UDI
POP-OB27-26 EUDAMEDFDA UDI
POP-HVR-110 EUDAMEDFDA UDI
POP-OB35-44 EUDAMEDFDA UDI
POP-OB27-44 EUDAMEDFDA UDI
POP-IVR-090 EUDAMEDFDA UDI
POP-GWR128-PKG6 EUDAMEDFDA UDI
POP-OB45-56 EUDAMEDFDA UDI
POP-OB35-52 EUDAMEDFDA UDI
POP-OB35-12 EUDAMEDFDA UDI
POP-OB35-24 EUDAMEDFDA UDI
POP-IB-40 EUDAMEDFDA UDI
POP-OB45-52 EUDAMEDFDA UDI
POP-LS27-12 EUDAMEDFDA UDI
POP-CB-40 EUDAMEDFDA UDI
POP-DCS127 EUDAMEDFDA UDI
POP-LS35-28 EUDAMEDFDA UDI
POP-OB45-20 EUDAMEDFDA UDI
POP-OB35-56 EUDAMEDFDA UDI
POP-IVL-130 EUDAMEDFDA UDI
POP-OB45-18 EUDAMEDFDA UDI
POP-LS35-40 EUDAMEDFDA UDI
POP-M3I EUDAMEDFDA UDI
POP-OB27-40 EUDAMEDFDA UDI
POP-LS27-28 EUDAMEDFDA UDI
POP-LS35-16 EUDAMEDFDA UDI
POP-HVR-090 EUDAMEDFDA UDI
POP-OB45-28 EUDAMEDFDA UDI
POP-IVL-140 EUDAMEDFDA UDI
POP-OB27-52 EUDAMEDFDA UDI
POP-OB45-44 EUDAMEDFDA UDI
POP-CB-35 EUDAMEDFDA UDI
LOCKING SCREW EUDAMED
BLADE EUDAMED
GUIDE WIRE EUDAMED
Connector EUDAMED
DEROTATION PIN EUDAMED
PLATE EUDAMED
POP-AB-70 EUDAMED
CORTICAL DRILL EUDAMED
POP-AB70 FDA UDI
Description
Locking Screw, Ø4.5 X 40mm FDA UDI
Locking Screw, Ø4.5 X 24mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 32mm FDA UDI
LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 2 FDA UDI
LOLLIPOP DEROTATION PIN Ø2.8 FDA UDI
Locking Screw, Ø4.5 X 14mm FDA UDI
M4 Connector For Child FDA UDI
Locking Screw, Ø2.7 X 24mm FDA UDI
BLADE, CHILD 60mm FDA UDI
Locking Screw, Ø4.5 X 22mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 24mm FDA UDI
Locking Screw, Ø3.5 X 22mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 48mm FDA UDI
Blade, Infant 25mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 26mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 60mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 48mm FDA UDI
Varus Plate, Infant 110° FDA UDI
Locking Screw, Ø3.5 X 36mm FDA UDI
Blade, Infant 30mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 14mm FDA UDI
POINT-TO-POINT FORCEPS FDA UDI
Polyaxial Compression Screw, Ø2.7 X 56mm FDA UDI
Locking Screw, Ø4.5 X 16mm FDA UDI
Locking Screw, Ø2.7 X 18mm FDA UDI
BLADE, INFANT 45mm FDA UDI
Blade, Adolescent 60mm FDA UDI
Valgus Plate, Adolescent 140° FDA UDI
Valgus Plate, Child 130° FDA UDI
Blade, Adolescent 70mm FDA UDI
LOLLIPOP GUIDE WIRE Ø2.0 x 254mm FDA UDI
Ø2.5mm CORTICAL DRILL FOR Ø3.5mm SCREWS FDA UDI
Valgus Plate, HD Adolescent 130° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 16mm FDA UDI
Varus Plate, Child 90° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 32mm FDA UDI
Blade, Child 45mm FDA UDI
Blade, Adolescent 40mm FDA UDI
Varus Plate, Adolescent 90° FDA UDI
Locking Screw, Ø2.7 X 14mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 36mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 12mm FDA UDI
Locking Screw, Ø4.5 X 28mm FDA UDI
Valgus Plate, HD Adolescent 120° FDA UDI
Varus Plate, Adolescent 100° FDA UDI
Locking Screw, Ø2.7 X 36mm FDA UDI
Locking Screw, Ø4.5 X 12mm FDA UDI
Blade, Adolescent 50mm FDA UDI
Locking Screw, Ø2.7 X 20mm FDA UDI
Blade, Child 30mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 16mm FDA UDI
Locking Screw, Ø3.5 X 20mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 26mm FDA UDI
Varus Plate, HD Adolescent 110° FDA UDI
Polyaxial Compression Screw, Ø3.5 X 44mm FDA UDI
Polyaxial Compression Screw, Ø2.7 X 44mm FDA UDI
Varus Plate, Infant 90° FDA UDI
LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 6 FDA UDI
Polyaxial Compression Screw, Ø4.5 X 56mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 52mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 12mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 24mm FDA UDI
BLADE, INFANT 40mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 52mm FDA UDI
Locking Screw, Ø2.7 X 12mm FDA UDI
Blade, Child 40mm FDA UDI
Ø2.0mm CORTICAL DRILL FOR Ø2.7mm SCREWS FDA UDI
Locking Screw, Ø3.5 X 28mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 20mm FDA UDI
Polyaxial Compression Screw, Ø3.5 X 56mm FDA UDI
Valgus Plate, Infant 130° FDA UDI
Polyaxial Compression Screw, Ø4.5 X 18mm FDA UDI
Locking Screw, Ø3.5 X 40mm FDA UDI
M3 Connector For Infant FDA UDI
Polyaxial Compression Screw, Ø2.7 X 40mm FDA UDI
Locking Screw, Ø2.7 X 28mm FDA UDI
Locking Screw, Ø3.5 X 16mm FDA UDI
Varus Plate, HD Adolescent 90° FDA UDI
Polyaxial Compression Screw, Ø4.5 X 28mm FDA UDI
Valgus Plate, Infant 140° FDA UDI
Polyaxial Compression Screw, Ø2.7 X 52mm FDA UDI
Polyaxial Compression Screw, Ø4.5 X 44mm FDA UDI
Blade, Child 35mm FDA UDI

Identifiers

Catalog Number
POP-LS45-40 FDA UDI
POP-LS45-24 FDA UDI
POP-OB45-32 FDA UDI
POP-GWR120-PKG2 FDA UDI
POP-GWR128 FDA UDI
POP-LS45-14 FDA UDI
POP-M4C FDA UDI
POP-LS27-24 FDA UDI
POP-CB-60 FDA UDI
POP-LS45-22 FDA UDI
POP-OB45-24 FDA UDI
POP-LS35-22 FDA UDI
POP-OB35-48 FDA UDI
POP-IB-25 FDA UDI
POP-OB45-26 FDA UDI
POP-OB27-60 FDA UDI
POP-OB45-48 FDA UDI
POP-IVR-110 FDA UDI
POP-LS35-36 FDA UDI
POP-IB-30 FDA UDI
POP-OB35-14 FDA UDI
GIN-FCP100 FDA UDI
POP-OB27-56 FDA UDI
POP-LS45-16 FDA UDI
POP-LS27-18 FDA UDI
POP-IB-45 FDA UDI
POP-AB-60 FDA UDI
POP-AVL-140 FDA UDI
POP-CVL-130 FDA UDI
POP-AB70 FDA UDI
POP-GWR120 FDA UDI
POP-DCS135 FDA UDI
POP-HVL-130 FDA UDI
POP-OB35-16 FDA UDI
POP-CVR-090 FDA UDI
POP-OB35-32 FDA UDI
POP-CB-45 FDA UDI
POP-AB-40 FDA UDI
POP-AVR-090 FDA UDI
POP-LS27-14 FDA UDI
POP-OB35-36 FDA UDI
POP-OB45-12 FDA UDI
POP-LS45-28 FDA UDI
POP-HVL-120 FDA UDI
POP-AVR-100 FDA UDI
POP-LS27-36 FDA UDI
POP-LS45-12 FDA UDI
POP-AB-50 FDA UDI
POP-LS27-20 FDA UDI
POP-CB-30 FDA UDI
POP-OB27-16 FDA UDI
POP-LS35-20 FDA UDI
POP-OB27-26 FDA UDI
POP-HVR-110 FDA UDI
POP-OB35-44 FDA UDI
POP-OB27-44 FDA UDI
POP-IVR-090 FDA UDI
POP-GWR128-PKG6 FDA UDI
POP-OB45-56 FDA UDI
POP-OB35-52 FDA UDI
POP-OB35-12 FDA UDI
POP-OB35-24 FDA UDI
POP-IB-40 FDA UDI
POP-OB45-52 FDA UDI
POP-LS27-12 FDA UDI
POP-CB-40 FDA UDI
POP-DCS127 FDA UDI
POP-LS35-28 FDA UDI
POP-OB45-20 FDA UDI
POP-OB35-56 FDA UDI
POP-IVL-130 FDA UDI
POP-OB45-18 FDA UDI
POP-LS35-40 FDA UDI
POP-M3I FDA UDI
POP-OB27-40 FDA UDI
POP-LS27-28 FDA UDI
POP-LS35-16 FDA UDI
POP-HVR-090 FDA UDI
POP-OB45-28 FDA UDI
POP-IVL-140 FDA UDI
POP-OB27-52 FDA UDI
POP-OB45-44 FDA UDI
POP-CB-35 FDA UDI
Primary DI / UDI-DI
07540194008848 EUDAMEDFDA UDI
07540194005267 EUDAMEDFDA UDI
07540194005212 EUDAMEDFDA UDI
07540194005014 EUDAMEDFDA UDI
07540194010421 EUDAMEDFDA UDI
07540194009029 EUDAMEDFDA UDI
07540194005168 EUDAMEDFDA UDI
07540194006707 EUDAMEDFDA UDI
07540194005762 EUDAMEDFDA UDI
07540194013132 EUDAMEDFDA UDI
07540194005205 EUDAMEDFDA UDI
07540194004994 EUDAMEDFDA UDI
07540194005434 EUDAMEDFDA UDI
07540194005588 EUDAMEDFDA UDI
07540194005687 EUDAMEDFDA UDI
07540194006578 EUDAMEDFDA UDI
07540194005922 EUDAMEDFDA UDI
07540194005052 EUDAMEDFDA UDI
07540194005649 EUDAMEDFDA UDI
07540194005489 EUDAMEDFDA UDI
07540194005694 EUDAMEDFDA UDI
07540194006585 EUDAMEDFDA UDI
07540194005915 EUDAMEDFDA UDI
07540194005175 EUDAMEDFDA UDI
07540194005731 EUDAMEDFDA UDI
07540194013156 EUDAMEDFDA UDI
07540194005137 EUDAMEDFDA UDI
07540194004970 EUDAMEDFDA UDI
07540194005328 EUDAMEDFDA UDI
07540194005151 EUDAMEDFDA UDI
07540194009012 EUDAMEDFDA UDI
07540194008961 EUDAMEDFDA UDI
07540194004901 EUDAMEDFDA UDI
07540194006035 EUDAMEDFDA UDI
07540194005281 EUDAMEDFDA UDI
07540194005540 EUDAMEDFDA UDI
07540194005373 EUDAMEDFDA UDI
07540194005090 EUDAMEDFDA UDI
07540194004925 EUDAMEDFDA UDI
07540194005717 EUDAMEDFDA UDI
07540194005557 EUDAMEDFDA UDI
07540194005977 EUDAMEDFDA UDI
07540194005236 EUDAMEDFDA UDI
07540194004895 EUDAMEDFDA UDI
07540194004932 EUDAMEDFDA UDI
07540194005809 EUDAMEDFDA UDI
07540194006660 EUDAMEDFDA UDI
07540194005113 EUDAMEDFDA UDI
07540194005748 EUDAMEDFDA UDI
07540194005342 EUDAMEDFDA UDI
07540194006059 EUDAMEDFDA UDI
07540194005427 EUDAMEDFDA UDI
07540194006653 EUDAMEDFDA UDI
07540194004888 EUDAMEDFDA UDI
07540194005571 EUDAMEDFDA UDI
07540194005885 EUDAMEDFDA UDI
07540194005625 EUDAMEDFDA UDI
07540194010438 EUDAMEDFDA UDI
07540194005076 EUDAMEDFDA UDI
07540194005595 EUDAMEDFDA UDI
07540194005991 EUDAMEDFDA UDI
07540194005526 EUDAMEDFDA UDI
07540194013149 EUDAMEDFDA UDI
07540194005069 EUDAMEDFDA UDI
07540194006684 EUDAMEDFDA UDI
07540194005366 EUDAMEDFDA UDI
07540194008954 EUDAMEDFDA UDI
07540194005465 EUDAMEDFDA UDI
07540194004987 EUDAMEDFDA UDI
07540194005601 EUDAMEDFDA UDI
07540194005663 EUDAMEDFDA UDI
07540194006554 EUDAMEDFDA UDI
07540194005496 EUDAMEDFDA UDI
07540194006691 EUDAMEDFDA UDI
07540194005878 EUDAMEDFDA UDI
07540194005786 EUDAMEDFDA UDI
07540194005403 EUDAMEDFDA UDI
07540194004864 EUDAMEDFDA UDI
07540194005007 EUDAMEDFDA UDI
07540194005670 EUDAMEDFDA UDI
07540194005908 EUDAMEDFDA UDI
07540194005045 EUDAMEDFDA UDI
07540194005359 EUDAMEDFDA UDI
Basic UDI-DI
7540194POP-PFCP5N EUDAMED
7540194POP-SCW2Y EUDAMED
7540194POP-BLDXV EUDAMED
7540194POP-GWXK EUDAMED
7540194POP-CNTZ8 EUDAMED
7540194POP-LDPZF EUDAMED
7540194POP-PLT36 EUDAMED
7540194POP-DRWY EUDAMED
510(k) Number
K170704 FDA UDI
FDA Product Code
KTT FDA UDI
LXH FDA UDI
HTW FDA UDI
EMDN Code
L091103 ORTHOPAEDIC PROSTHESES FORCEPS, REUSABLE EUDAMED
P09120601 CORTICAL SCREWS EUDAMED
P09120504 OSTEOSYNTHESIS BLADE-PLATE SYSTEMS EUDAMED
Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
P09120402 SCREWS EUDAMED
Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Implantable orthopaedic/craniofacial device connection screw FDA UDI
Femoral fixation plate/blade FDA UDI
Bone holding forceps FDA UDI
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIb EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.4540 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 40 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI
Length — 24 Millimeter FDA UDI
Length — 32 Millimeter FDA UDI
Length — 254 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI
Length — 229 Millimeter FDA UDI
Outer Diameter — 2.8 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Outer Diameter — 2.7 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI
Length — 22 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI
Length — 48 Millimeter FDA UDI
Length — 25 Millimeter FDA UDI
Length — 26 Millimeter FDA UDI
Angle — 110 degree FDA UDI
Length — 36 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI
Length — 56 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI
Length — 18 Millimeter FDA UDI
Length — 45 Millimeter FDA UDI
Angle — 140 degree FDA UDI
Angle — 130 degree FDA UDI
Length — 70 Millimeter FDA UDI
Length — 220 Millimeter FDA UDI
Outer Diameter — 2.5 Millimeter FDA UDI
Angle — 90 degree FDA UDI
Length — 12 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI
Angle — 120 degree FDA UDI
Angle — 100 degree FDA UDI
Length — 50 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI
Length — 44 Millimeter FDA UDI
Length — 52 Millimeter FDA UDI
Length — 35 Millimeter FDA UDI

The Locking Pediatric Osteotomy Plate system by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OrthoPediatrics Canada ULC
EUDAMED SRN
CA-MF-000013010
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (166)

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