Hybrid Fixator System 1
Hybrid Fixator System 1 (80121) 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 16 Sep 2016 (UDI-DI 18032568860559), 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 | Number18032568860559 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944092 | Date4 Apr 1995 | StatusActive |
Official records
- AccessGUDID record 18032568860559
- FDA 510(k) database K944092
Across registries
- FDA 510(k) K944092 decided 4 Apr 1995 Active
- FDA GUDID UDI-DI 18032568860559 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K944092
- Listed FDA GUDID 18032568860559
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hybrid Fixator System
- Generic name
- Orthopaedic bone wire
- Model / Ref / Catalog
- 1, 80121
- Description
- X-WIRE WITH CENTRAL OLIVE DIAMETER 2 MM LENGTH 400 MM
- Primary DI / UDI-DI
- 18032568860559
- 510(k) Number
- FDA product code
- JEC
- GMDN term
- Orthopaedic bone wire
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 2 MillimeterLength — 400 Millimeter