EXPert Nail 04.031.000S
by Synthes
EXPert Nail 04.031.000S (04031000S) is a Class II device made by Synthes, cleared under FDA 510(k) K070843 on 2 May 2007 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982093790), 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 | Number10886982093790 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070843 | Date2 May 2007 | StatusActive |
Official records
- AccessGUDID record 10886982093790
- FDA 510(k) database K070843
Across registries
- FDA 510(k) K070843 decided 2 May 2007 Active
- FDA GUDID UDI-DI 10886982093790 listed 14 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K070843
- Listed FDA GUDID 10886982093790
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXPert Nail
- Generic name
- Bone nail implantable cap
- Model / Ref / Catalog
- 04.031.000S, 04031000S
- Primary DI / UDI-DI
- 10886982093790
- 510(k) Number
- FDA product code
- HSB
- GMDN term
- Bone nail implantable cap
- Device class
- Class II
- Regulation number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization