Identity
- Trade Name
- MiniBunion™ FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable 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
- MiniBunion Drill 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
- 3100-0001 FDA UDI
- Primary DI / UDI-DI
- 00815432026999 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, 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
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: Fluted surgical drill bit, reusable
MiniBunion™ by Crossroads Extremity Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
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- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
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- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
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 53771d5e-5ac6-4da4-825f-007d90184fe5 35 fields · synced May 30, 2026