Restoris Esyntial 180748-4
Restoris Esyntial 180748-4 is a Class II device made by MAKO Surgical Corp., cleared under FDA 510(k) K133039 on 10 Dec 2013 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00848486015817), 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 | Number00848486015817 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133039 | Date10 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 00848486015817
- FDA 510(k) database K133039
Across registries
- FDA 510(k) K133039 decided 10 Dec 2013 Active
- FDA GUDID UDI-DI 00848486015817 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K133039
- Listed FDA GUDID 00848486015817
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Restoris Esyntial
- Generic name
- Unicondylar knee prosthesis
- Model / Ref / Catalog
- 180748-4
- Primary DI / UDI-DI
- 00848486015817
- 510(k) Number
- FDA product code
- HRY, OIY, HSX, KRR, NPJ
- GMDN term
- Unicondylar knee prosthesis
- Device class
- Class II
- Regulation number
- 888.3530, 888.3560, 888.3520, 888.3540
- GUDID distribution status
- In Commercial Distribution