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Dr Paley’s Osteotomy System
EUDAMEDFDA UDIClass I (EU MDR)
Ref DRPAP-902Model PINRef DRPO-706Model OSTEOTOMERef POS-INF150Model EMPTY INSTRUMENT CASE
Identity
- Trade Name
- Dr Paley’s Osteotomy System EUDAMEDDr.Paleys Osteotomy System FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDIGeneral internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Dr PALEY AUXILIARY PIN FDA UDIPEDIATRIC OSTEOTOME SET - FULL CASE FDA UDI
- Model / Reference
- PIN EUDAMEDDRPAP-902 EUDAMEDFDA UDIPOS-INF150 EUDAMEDFDA UDIOSTEOTOME EUDAMEDDRPO-706 EUDAMEDEMPTY INSTRUMENT CASE EUDAMED
- Description
- Dr PALEY AUXILIARY PIN FDA UDIPEDIATRIC OSTEOTOME SET - FULL CASE FDA UDI
Identifiers
- Catalog Number
- DRPAP-902 FDA UDIPOS-INF150 FDA UDI
- Primary DI / UDI-DI
- 07540194010490 EUDAMEDFDA UDI07540194016010 EUDAMEDFDA UDI07540194018168 EUDAMED
- Basic UDI-DI
- 7540194DRP-PINV9 EUDAMED7540194DRP-OSTT3S EUDAMED7540194DRP-EINCWB EUDAMED
- FDA Product Code
- LXH FDA UDIOJH FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMEDL090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMEDL0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDIGeneral internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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 UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dr Paley’s Osteotomy 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 | 7540194DRP-PINV9 | 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 (5)
- EUDAMED 89c8f3a9-520d-4ed0-b345-1d1332ebec42 61 fields · synced Jul 19, 2026
- FDA UDI 141d8c4e-5079-4ea3-9a48-8e86cbb77f48 36 fields · synced May 30, 2026
- FDA UDI 13d3ae43-1949-4e56-8b6b-524bace9ce3f 35 fields · synced May 30, 2026
- EUDAMED 26791a6b-e7a5-4322-b303-e88a01474f5e 61 fields · synced Jul 9, 2026
- EUDAMED 7294a95a-e1f8-47ff-959c-f1e0a3ecc957 61 fields · synced Jul 19, 2026