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The Hinge Pediatric Plating System
EUDAMEDFDA UDIClass I (EU MDR)
Ref HPH100Model CROC HOLDERRef HPD130Model DRILLRef HPS020Model SCREWRef HPS035Ref HPS020-PKG2Ref HPI016Model PLATE
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDICannulated surgical drill bit, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- HINGE PLATE DRILL 3.0mm EUDAMEDFDA UDISCREW 20MM LENGTH EUDAMEDSMALL PLATE 12MM LENGTH EUDAMEDScrew Ø4.5mm x 35mm Length FDA UDIScrew Ø4.5mm x 20mm Length FDA UDIMedium Plate 16mm Length FDA UDIHINGE PLATE CROC HOLDER FDA UDI
- Model / Reference
- CROC HOLDER EUDAMEDHPH100 EUDAMEDFDA UDIHPS035 EUDAMEDFDA UDIHPS020-PKG2 EUDAMEDFDA UDIHPD130 EUDAMEDFDA UDIHPI016 EUDAMEDFDA UDIHPS020 EUDAMEDFDA UDIDRILL EUDAMEDSCREW EUDAMEDPLATE EUDAMED
- Description
- Screw Ø4.5mm x 35mm Length FDA UDIScrew Ø4.5mm x 20mm Length FDA UDIHINGE PLATE DRILL 3.0mm FDA UDIMedium Plate 16mm Length FDA UDIHINGE PLATE CROC HOLDER FDA UDI
Identifiers
- Catalog Number
- HPS035 FDA UDIHPS020-PKG2 FDA UDIHPD130 FDA UDIHPI016 FDA UDIHPS020 FDA UDIHPH100 FDA UDI
- Primary DI / UDI-DI
- 07540194007681 EUDAMEDFDA UDI07540194000668 EUDAMEDFDA UDI07540194000590 EUDAMEDFDA UDI07540194007667 EUDAMEDFDA UDI07540194000576 EUDAMEDFDA UDI07540194000637 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-CHDPE EUDAMED7540194HP-DRTY EUDAMED7540194HP-SCWSM EUDAMED7540194HP-PLTST EUDAMED
- 510(k) Number
- K090440 FDA UDI
- FDA Product Code
- HWC FDA UDIHTW FDA UDIHRS FDA UDILXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDZ12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMEDP09120601 CORTICAL SCREWS EUDAMEDP09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDICannulated surgical drill bit, reusable FDA UDIOrthopaedic fixation plate, non-bioabsorbable FDA UDISurgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.4540 FDA UDI888.3030 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDILength — 20 Millimeter FDA UDILength — 111.8 Millimeter FDA UDIOuter Diameter — 2.8 Millimeter FDA UDILumen/Inner Diameter — 1.25 Millimeter FDA UDILength — 16 Millimeter FDA UDI
The Hinge Pediatric Plating System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194HP-CHDPE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (12)
- EUDAMED c6b8752a-bccb-4c39-9dda-412abe713d37 61 fields · synced Sep 17, 2026
- FDA UDI 33322f65-1cb7-4079-8364-2002cf990a37 38 fields · synced May 29, 2026
- FDA UDI 020af5c0-7d55-4244-a3a5-54a02cc284bd 38 fields · synced May 29, 2026
- FDA UDI 3e8e4efd-7467-46c6-b057-2a183d579afe 37 fields · synced May 30, 2026
- FDA UDI e935feab-ddd6-4b04-af32-b4975c6816ee 38 fields · synced May 30, 2026
- FDA UDI a66775a5-6834-40a3-af78-b37b22818cc9 38 fields · synced May 30, 2026
- FDA UDI 0b0943b6-3365-4429-bcfa-e95c29ce6793 36 fields · synced May 30, 2026
- EUDAMED 29a351de-2663-4d61-b90d-45ef11d9cd0f 61 fields · synced Jul 11, 2026
- EUDAMED c97309b2-9a10-482d-9e29-ecaa2d39da64 61 fields · synced Jul 11, 2026
- EUDAMED 7958b6d0-c867-4383-a2bd-a83585b26f26 61 fields · synced Jul 14, 2026
- EUDAMED 054029cc-5431-4758-9455-b09afeb52406 61 fields · synced Jul 27, 2026
- EUDAMED a7336c69-6300-4771-a968-23a6cd367754 61 fields · synced Sep 17, 2026