REVISION HIP - Ti6Al4V
REVISION HIP - Ti6Al4V (3810.15.010) is a Class II device made by Limacorporate, cleared under FDA 510(k) K151739 on 23 Nov 2015 and listed in FDA GUDID since 6 May 2016 (UDI-DI 08033390003841), 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 | Number08033390003841 | Date6 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151739 | Date23 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 08033390003841
- FDA 510(k) database K151739
Across registries
- FDA 510(k) K151739 decided 23 Nov 2015 Active
- FDA GUDID UDI-DI 08033390003841 listed 6 May 2016 Listed
Timeline
- Cleared FDA 510(k) K151739
- Listed FDA GUDID 08033390003841
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Revision
- Generic name
- Revision uncoated femoral stem prosthesis
- Model / Ref / Catalog
- REVISION HIP - Ti6Al4V, 3810.15.010
- Description
- Uncemented Stem Dia=14mm - L=140mm
- Primary DI / UDI-DI
- 08033390003841
- 510(k) Number
- FDA product code
- KWY, LPH, LZO
- GMDN term
- Revision uncoated femoral stem prosthesis
- Device class
- Class II
- Regulation number
- 888.3390, 888.3358, 888.3353
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Revision uncoated femoral stem prosthesis.