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Ortholox

by Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ 12 variants

Ref 31-054-0008, 91-000-000, 31-054-0004, 21-001-6450, 41-089-L026, 41-092-L032, 41-091-C028, 41-092-BT18, 41-092-L020, 41-092-BT14, 41-092-L016, 41-092-L024, 22-003-5550, 41-091-C032, 41-091-C036, 41-091-C038, 22-002-5550, 41-092-BT16, 41-092-L075, 41-092-L012, 31-053-L015, 23-001-5525, 41-092-L034, 31-053-R013, 41-091-C030, 41-092-L022, 31-053-L013, 41-092-L036, 31-056-L010, 41-092-L060, 22-002-5500, 41-092-L050, 31-053-0005, 41-091-0000, 31-054-0002, 31-053-0004, 41-092-L028, 31-052-0008, 31-052-0012, 41-091-C034, 31-053-0007, 41-092-L026, 41-092-L044

Active European Union

CE MDR CE MDD

Valid until

14 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026/0029 Date15 Jun 2026IssuedStatusActive expires 14 Jun 2031
European UnionCE/MDD NumberB-08682320051799 Basic UDI-DI Date12 Aug 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR.2292-2026/0029 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    15 Jun 2026
    Expires
    14 Jun 2031
  • MDR.2292-2026/0030 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    15 Jun 2026
    Expires
    14 Jun 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
Ortholox
Ortholox UHMWPE Orthopedics Cerclage Band System (Ti. Locking-Low Profile) - 6.0 x 450mm
Ortholox Locking Cortex Screw Self-Tapping - 3.5 x 26mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 32mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 20mm
Ortholox Locking Cortex Screw Self-Tapping, Blunt Tip - 5.0 x 14mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 16mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 24mm
Ortholox Locking Cortex Screw Self-Tapping, Blunt Tip - 5.0 x 16mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 12mm
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook, Left - 15 Holes, 4.5/5.0mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 34mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 22mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 36mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 60mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 50mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 28mm
Ortholox Locking Periprosthetic Support Straight Cable-Plate - 12 Holes, 4.5/5.0mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 26mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 44mm
Ortholox® UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Blunt Needle) - 5.0 x 550mm
Ortholox® UHMWPE Spinal Posterior Fixation Dual Band System, Low Profile (f/5.5mm Rod -Ti. Locking) - 5.0 x 250mm
Ortholox® Orthopedics Cerclage Band System Instrument Set - Complete
Ortholox® UHMWPE Orthopedics Cerclage Band System (Ti. Locking-Low Profile) - 6.0 x 450mm
Ortholox® UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Sharp Needle) - 5.0 x 550mm
Ortholox® UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Sharp Needle) - 5.0 x 500mm
Device Name
Ortholox Locking Periprosthetic Attachment Plate - 8 Holes
Orthopedics Cerclage Band System Instrument Set - Complete
Ortholox Locking Periprosthetic Attachment Plate - 4 Holes
Ortholox Cortex Screw Self-Tapping - 4.5 x 28mm
Ortholox Locking Cortex Screw Self-Tapping, Blunt Tip - 5.0 x 18mm
Ortholox UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Blunt Needle) - 5.0 x 550mm
Ortholox Cortex Screw Self-Tapping - 4.5 x 32mm
Ortholox Cortex Screw Self-Tapping - 4.5 x 36mm
Ortholox Cortex Screw Self-Tapping - 4.5 x 38mm
Ortholox UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Sharp Needle) - 5.0 x 550mm
Ortholox Locking Cortex Screw Self-Tapping - 5.0 x 75mm
Ortholox UHMWPE Spinal Posterior Fixation Dual Band System, Low Profile (f/5.5mm Rod -Ti. Locking) - 5.0 x 250mm
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook, Right - 13 Holes, 4.5/5.0mm
Ortholox Cortex Screw Self-Tapping - 4.5 x 30mm
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook, Left - 13 Holes, 4.5/5.0mm
Ortholox Locking Periprosthetic Support Condylar Distal Femur Cable-Plate, Left - 10 Holes, 4.5/5.0mm
Ortholox UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Sharp Needle) - 5.0 x 500mm
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook - 5 Holes, 4.5/5.0mm
Ortholox Locking Insert Connecting Screw - 4.5mm
Ortholox Locking Periprosthetic Attachment Plate - 2 Holes
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook - 4 Holes, 4.5/5.0mm
Ortholox Locking Periprosthetic Support Straight Cable-Plate - 8 Holes, 4.5/5.0mm
Ortholox Cortex Screw Self-Tapping - 4.5 x 34mm
Ortholox Locking Periprosthetic Support Trochanter Femur Cable-Plate w/ Hook - 7 Holes, 4.5/5.0mm
UHMWPE Band System - Sterile
UHMWPE Spinal Posterior Fixation Dual Band System - Sterile
Non-Sterile Reusable Surgical Instruments - Sets
Model / Reference
31-054-0008, 91-000-000, 31-054-0004, 21-001-6450, 41-089-L026, 41-092-L032, 41-091-C028, 41-092-BT18, 41-092-L020, 41-092-BT14, 41-092-L016, 41-092-L024, 22-003-5550, 41-091-C032, 41-091-C036, 41-091-C038, 22-002-5550, 41-092-BT16, 41-092-L075, 41-092-L012, 31-053-L015, 23-001-5525, 41-092-L034, 31-053-R013, 41-091-C030, 41-092-L022, 31-053-L013, 41-092-L036, 31-056-L010, 41-092-L060, 22-002-5500, 41-092-L050, 31-053-0005, 41-091-0000, 31-054-0002, 31-053-0004, 41-092-L028, 31-052-0008, 31-052-0012, 41-091-C034, 31-053-0007, 41-092-L026, 41-092-L044
Primary DI / UDI-DI
08682320051799, 08682320050150, 08682320051775, 08682320051058, 08682320053151, 08682320054080, 08682320053410, 08682320053960, 08682320054028, 08682320053946, 08682320054004, 08682320054042, 08682320051201, 08682320053434, 08682320053458, 08682320053465, 08682320051171, 08682320053953, 08682320054226, 08682320053984, 08682320051706, 08682320051409, 08682320054097, 08682320051737, 08682320053427, 08682320054035, 08682320051690, 08682320054103, 08682320052345, 08682320054196, 08682320051164, 08682320054172, 08682320051652, 08682320053328, 08682320051768, 08682320051645, 08682320054066, 08682320051577, 08682320051591, 08682320053441, 08682320051669, 08682320054059, 08682320054141
Basic UDI-DI
B-08682320051799, B-08682320050150, B-08682320051775, B-08682320051058, B-08682320053151, B-08682320054080, B-08682320053410, B-08682320053960, B-08682320054028, B-08682320053946, B-08682320054004, B-08682320054042, B-08682320051201, B-08682320053434, B-08682320053458, B-08682320053465, B-08682320051171, B-08682320053953, B-08682320054226, B-08682320053984, B-08682320051706, B-08682320051409, B-08682320054097, B-08682320051737, B-08682320053427, B-08682320054035, B-08682320051690, B-08682320054103, B-08682320052345, B-08682320054196, B-08682320051164, B-08682320054172, B-08682320051652, B-08682320053328, B-08682320051768, B-08682320051645, B-08682320054066, B-08682320051577, B-08682320051591, B-08682320053441, B-08682320051669, B-08682320054059, B-08682320054141, 868232005SEBSH7, 868232005SPBSJW, 868232005SSTQQ
EMDN Code
P09120599, L0919, P09120302, P09120601, P09120699, P09120503, P09070302
Device Class
Class IIb
Class I
Class III
EU market of registration
Belgium
Türkiye
Greece
Italy
Spain
Denmark

Manufacturer details

EUDAMED SRN
TR-MF-000027137

Other devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Sterile NoEUDAMEDYesEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED

Other properties (11)

  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No