Fragment Fixation System 1
Fragment Fixation System 1 (W2200) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K172698 on 7 Feb 2018 and listed in FDA GUDID since 28 Mar 2018 (UDI-DI 18032568865523), 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 | Number18032568865523 | Date28 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172698 | Date7 Feb 2018 | StatusActive |
Official records
- AccessGUDID record 18032568865523
- FDA 510(k) database K172698
Across registries
- FDA 510(k) K172698 decided 7 Feb 2018 Active
- FDA GUDID UDI-DI 18032568865523 listed 28 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K172698
- Listed FDA GUDID 18032568865523
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fragment Fixation System
- Generic name
- Implantable bone washer
- Model / Ref / Catalog
- 1, W2200
- Primary DI / UDI-DI
- 18032568865523
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Implantable bone washer
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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