← Back to catalogue
The Locking Pediatric Osteotomy Plate system
EUDAMEDFDA UDIClass I (EU MDR)
Ref POP-OTG201Model OSTEOTOMY GUIDE
Identity
- Trade Name
- The Locking Pediatric Osteotomy Plate system EUDAMEDThe Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- OSTEOTOMY GUIDE, VALGUS CHILD FDA UDI
- Model / Reference
- OSTEOTOMY GUIDE EUDAMEDPOP-OTG201 EUDAMEDFDA UDI
- Description
- OSTEOTOMY GUIDE, VALGUS CHILD FDA UDI
Identifiers
- Catalog Number
- POP-OTG201 FDA UDI
- Primary DI / UDI-DI
- 07540194009180 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194POP-OSTGDM7 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Osteotomy guide, 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
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 UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA 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
The Locking Pediatric Osteotomy Plate system by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7540194POP-OSTGDM7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED b6c61d35-1158-40d9-b0eb-f1e910f4ed70 61 fields · synced May 30, 2026
- FDA UDI e8674bcc-130d-4797-bf4c-283cecee7dee 36 fields · synced May 30, 2026