Identity
- Trade Name
- MiniBunion™ FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- The MiniBunion™ Implant System is indicated for stabilization and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of an intramedullary implant and screws. FDA UDI
- Model / Reference
- MinBunion Capital Fragment Guide Kit - Sterile FDA UDI
- Description
- The MiniBunion™ Implant System is indicated for stabilization and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of an intramedullary implant and screws. FDA UDI
Identifiers
- Catalog Number
- 3100-0003 FDA UDI
- Primary DI / UDI-DI
- 00815432029297 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical drill guide, single-use
MiniBunion™ by Crossroads Extremity Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Crossroads Extremity Systems Llc
Sources (1)
- FDA UDI 50df2925-1cdb-4dfd-bc8c-f6c191f02dbc 35 fields · synced May 31, 2026