Identity
- Trade Name
- CoLag EUDAMEDFDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Lag Screw Sterile Instruments, Active EUDAMEDCoLag Single Use Kit - Dia. 3.0 FDA UDI
- Model / Reference
- P06 S0003 EUDAMEDFDA UDI
- Description
- CoLag Single Use Kit - Dia. 3.0 FDA UDI
Identifiers
- Catalog Number
- P06 S0003 FDA UDI
- Primary DI / UDI-DI
- 00810021866079 EUDAMEDFDA UDI
- Basic UDI-DI
- 0810175502574A EUDAMED
- 510(k) Number
- K170518 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint prosthesis implantation kit, single-use
CoLag by In2Bones, USA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0810175502574A | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED 625973ca-1007-4746-9495-274845cddfd1 61 fields · synced Jun 8, 2026
- FDA UDI 96cf2ccc-076e-4e94-9e90-8ff9ae62190d 36 fields · synced May 30, 2026