Hinge Pediatric Plating System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Small Plate 12mm Length EUDAMEDFDA UDI
- Model / Reference
- HPI012 EUDAMEDFDA UDIPLATE EUDAMED
- Description
- Small Plate 12mm Length FDA UDI
Identifiers
- Catalog Number
- HPI012 FDA UDI
- Primary DI / UDI-DI
- 07540194000569 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-PLTST EUDAMED
- 510(k) Number
- K090440 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Hinge Pediatric Plating System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K090440 also covers:
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 85b5c9f8-635d-41b8-a6ec-22142816d8ec 38 fields · synced Jun 18, 2026
- EUDAMED 29a66081-def8-4696-9b57-8ef701296bd1 61 fields · synced Jun 18, 2026