Identity
- Trade Name
- CoLink EUDAMEDFDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Mini Plates Non-sterile Instruments, Active EUDAMED2 MTP PLATE TRIAL,NX,NARROW,4° DF,6H,RIGHT,NON-STERILE FDA UDI
- Model / Reference
- P04 N0341 EUDAMEDFDA UDI
- Description
- 2 MTP PLATE TRIAL,NX,NARROW,4° DF,6H,RIGHT,NON-STERILE FDA UDI
Identifiers
- Catalog Number
- P04 N0341 FDA UDI
- Primary DI / UDI-DI
- 00810021863764 EUDAMEDFDA UDI
- Basic UDI-DI
- 0810175502674D EUDAMED
- 510(k) Number
- K201149 FDA UDI
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic implant impactor, reusable
CoLink 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 | 0810175502674D | 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 014611f5-a0da-40ba-8c20-a19822f324ad 61 fields · synced May 31, 2026
- FDA UDI ebd557ce-7aea-4ada-b722-649a5d1965f5 36 fields · synced May 30, 2026