Fragment Fixation System 1
Fragment Fixation System 1 (W10000) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K944092 on 4 Apr 1995 and listed in FDA GUDID since 19 Apr 2019 (UDI-DI 18053504366416), active as of 23 Oct 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 | Number18053504366416 | Date19 Apr 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944092 | Date4 Apr 1995 | StatusActive |
Official records
- AccessGUDID record 18053504366416
- FDA 510(k) database K944092
Across registries
- FDA 510(k) K944092 decided 4 Apr 1995 Active
- FDA GUDID UDI-DI 18053504366416 listed 19 Apr 2019 Listed
Timeline
- Cleared FDA 510(k) K944092
- Listed FDA GUDID 18053504366416
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fragment Fixation System
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / Ref / Catalog
- 1, W10000
- Primary DI / UDI-DI
- 18053504366416
- 510(k) Number
- FDA product code
- JEC
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization