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 EUDAMEDLarge Plate 20mm Length FDA UDI
- Model / Reference
- HPI020 EUDAMEDFDA UDIPLATE EUDAMED
- Description
- Large Plate 20mm Length FDA UDI
Identifiers
- Catalog Number
- HPI020 FDA UDI
- Primary DI / UDI-DI
- 07540194000583 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 — 20 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
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI ab40e506-02a1-4cd5-9423-d0c83d4b2e5d 38 fields · synced Jun 19, 2026
- EUDAMED 7a844bf5-a30e-44aa-b068-2921e7f02777 61 fields · synced Jun 19, 2026