Identity
- Trade Name
- MiniBunion™ FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, 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 Instrument 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
- 3100-0000 FDA UDI
- Primary DI / UDI-DI
- 00815432026982 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use 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
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-useOrthopaedic inorganic implant inserter/extractor, single-useSurgical screwdriver, single-use
MiniBunion™ by Crossroads Extremity Systems Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Crossroads Extremity Systems Llc
Sources (1)
- FDA UDI 7fe1aa96-b3b8-4fa3-a714-04ed00e010fb 35 fields · synced May 30, 2026