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The Locking Pediatric Osteotomy Plate system
EUDAMEDFDA UDIClass I (EU MDR)
Ref GIN-SDR350Model SCREWDRIVER
Identity
- Trade Name
- The Locking Pediatric Osteotomy Plate system EUDAMEDThe Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- 3.5mm HEX SCREWDRIVER FDA UDI
- Model / Reference
- SCREWDRIVER EUDAMEDGIN-SDR350 EUDAMEDFDA UDI
- Description
- 3.5mm HEX SCREWDRIVER FDA UDI
Identifiers
- Catalog Number
- GIN-SDR350 FDA UDI
- Primary DI / UDI-DI
- 07540194008862 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194POP-HSDZG EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, 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
Category: Surgical screwdriver, reusable
The Locking Pediatric Osteotomy Plate system by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Surgical screwdriver, reusable.
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- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
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- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
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-HSDZG | 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 609ebd5d-ceb7-4cbd-a0f2-f8023706bed5 61 fields · synced Jun 8, 2026
- FDA UDI 05287563-e8bb-4532-923a-7d329b61e207 36 fields · synced May 29, 2026