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CoLag
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P06 S0004Ref P06 S0002Ref P06 206A00
Identity
- Trade Name
- CoLag EUDAMEDFDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Lag Screw Sterile Instruments, Active EUDAMEDNon-patient-contacting Class I instruments, Non-Active EUDAMEDCoLag Single Use Kit - Dia. 4.0 FDA UDICoLag Single Use Kit - Dia. 2.0/2.5 FDA UDI
- Model / Reference
- P06 S0004 EUDAMEDFDA UDIP06 S0002 EUDAMEDFDA UDIP06 206A00 EUDAMED
- Description
- CoLag Single Use Kit - Dia. 4.0 FDA UDICoLag Single Use Kit - Dia. 2.0/2.5 FDA UDI
Identifiers
- Catalog Number
- P06 S0004 FDA UDIP06 S0002 FDA UDI
- Primary DI / UDI-DI
- 00810021866086 EUDAMEDFDA UDI00810021866062 EUDAMEDFDA UDI00810021866970 EUDAMED
- Basic UDI-DI
- 0810175502574A EUDAMED08101755028147 EUDAMED
- 510(k) Number
- K170518 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDV0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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 (8)
- EUDAMED cced66fa-3554-44db-8489-4b4351559987 61 fields · synced Sep 17, 2026
- EUDAMED 6b5e7f56-e4c4-4d54-a747-6e1e24dd6403 61 fields · synced May 19, 2026
- EUDAMED 2392dfd0-b00b-4cf8-9252-4a786c8e1258 61 fields · synced May 19, 2026
- FDA UDI 0d0a0950-6971-4166-baa6-f869e94d29cb 36 fields · synced May 30, 2026
- FDA UDI 17681897-35a4-40a8-8d19-f428612765ed 36 fields · synced May 30, 2026
- EUDAMED c6f16aa5-03bb-455b-983c-83e2bdfd4805 61 fields · synced Jul 11, 2026
- EUDAMED a5af0ae0-e0ef-4e34-8032-6301fdd06220 61 fields · synced Jul 28, 2026
- EUDAMED 0b876f2d-30c0-4f29-9c63-58f0f71f218f 61 fields · synced Sep 17, 2026