Identity
- Trade Name
- AFX FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- AFX, Locking Drill Guide, Ø2.5 FDA UDI
- Model / Reference
- P07 N0011 FDA UDI
- Description
- AFX, Locking Drill Guide, Ø2.5 FDA UDI
Identifiers
- Catalog Number
- P07 N0011 FDA UDI
- Primary DI / UDI-DI
- 00817906028324 FDA UDI
- 510(k) Number
- K181113 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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: Orthopaedic fixation implant alignment tool
Afx by In2Bones, USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation implant alignment tool.
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- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
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Cleared under the same submission
K181113 also covers:
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink Afx — In2Bones, USA
- CoLink Afx — In2Bones, USA
- CoLink Afx — In2Bones, USA
- CoLink™ Afx — In2Bones, USA
- CoLink™ Afx — In2Bones, USA
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 II | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
Sources (1)
- FDA UDI ee514056-9b61-442d-bd48-d2d87babb944 36 fields · synced Jun 8, 2026