Fragment Fixation System 1
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18032568865257 | Date8 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944092 | Date4 Apr 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
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- Withdrawn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, W1002
- Primary DI / UDI-DI
- 18032568865257
- 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
- Size
- Width — 154 Millimeter
Other devices from Orthofix, Inc.
Properties
Other properties (11)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No