Identity
- Trade Name
- CoLink Cfx FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- CoLink® CALC THREADED BENDING BAR FDA UDI
- Model / Reference
- P08 N0031 FDA UDI
- Description
- CoLink® CALC THREADED BENDING BAR FDA UDI
Identifiers
- Catalog Number
- P08 N0031 FDA UDI
- Primary DI / UDI-DI
- 00810021862170 FDA UDI
- 510(k) Number
- K200762 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Manual orthopaedic bender, reusable
CoLink Cfx by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200762 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- In2Bones, USA
Sources (1)
- FDA UDI 7ab58501-4f85-45f0-a95f-6d69e6da362c 36 fields · synced May 31, 2026