Identity
- Trade Name
- M-Fix 4mm FDA UDI
- Generic Name
- Acromioclavicular joint stabilization implant FDA UDI
- Device Name
- The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique. FDA UDI
- Model / Reference
- FG3004 FDA UDI
- Description
- The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860366001413 FDA UDI
- 510(k) Number
- K153211 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Acromioclavicular joint stabilization implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acromioclavicular joint stabilization implant
M-Fix 4mm by Coracoid Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153211 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 II | Pending data |
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Manufacturer
- Manufacturer
- Coracoid Solutions, Inc.
Sources (1)
- FDA UDI c241cdf8-be0d-480b-ba45-7b7c2f281481 34 fields · synced Jun 1, 2026