Fitbone Trochanteric 1
Fitbone Trochanteric 1 (7001217) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K250112 on 10 Apr 2025 and listed in FDA GUDID since 24 Jun 2025 (UDI-DI 18059015376364), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18059015376364 | Date24 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250112 | Date10 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 18059015376364
- FDA 510(k) database K250112
Across registries
- FDA 510(k) K250112 decided 10 Apr 2025 Active
- FDA GUDID UDI-DI 18059015376364 listed 24 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K250112
- Listed FDA GUDID 18059015376364
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fitbone Trochanteric
- Generic name
- Bone nail trial, reusable
- Model / Ref / Catalog
- 1, 7001217
- Primary DI / UDI-DI
- 18059015376364
- 510(k) Number
- FDA product code
- HSB
- GMDN term
- Bone nail trial, reusable
- Device class
- Class II
- Regulation number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 11 MillimeterLength — 217 Millimeter
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