The Hinge Pediatric Plating System
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- HINGE PLATE SNAP-ON SLEEVE -GEN2 FDA UDI
- Model / Reference
- SCREWDRIVER SHAFT -GEN2 EUDAMEDHP-SOS270 EUDAMEDFDA UDI
- Description
- HINGE PLATE SNAP-ON SLEEVE -GEN2 FDA UDI
Identifiers
- Catalog Number
- HP-SOS270 FDA UDI
- Primary DI / UDI-DI
- 07540194015068 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-SDSSG EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical screwdriver, reusable
The Hinge Pediatric Plating System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194HP-SDSSG | 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 (2)
- EUDAMED 8cc6ca25-3a01-4c85-8d1a-8622574f39ab 61 fields · synced Jun 18, 2026
- FDA UDI cfdf69e5-40d9-491e-a72e-426137a9482a 35 fields · synced May 27, 2026