Fragment Fixation System 1
Fragment Fixation System 1 (99-W1621) 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 1 Sep 2015 (UDI-DI 18033509852466), 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 | Number18033509852466 | Date1 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944092 | Date4 Apr 1995 | StatusActive |
Official records
- AccessGUDID record 18033509852466
- FDA 510(k) database K944092
Across registries
- FDA 510(k) K944092 decided 4 Apr 1995 Active
- FDA GUDID UDI-DI 18033509852466 listed 1 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K944092
- Listed FDA GUDID 18033509852466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fragment Fixation System
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- 1, 99-W1621
- Primary DI / UDI-DI
- 18033509852466
- 510(k) Number
- FDA product code
- JEC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 120 Millimeter