Precise Offset Total 700-625
Precise Offset Total 700-625 is a Class II device made by Grace Medical, Inc., cleared under FDA 510(k) K061853 on 18 Aug 2006 and listed in FDA GUDID since 18 Feb 2016 (UDI-DI 00844505005708), active as of 22 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 | Number00844505005708 | Date18 Feb 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061853 | Date18 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00844505005708
- FDA 510(k) database K061853
Across registries
- FDA 510(k) K061853 decided 18 Aug 2006 Active
- FDA GUDID UDI-DI 00844505005708 listed 18 Feb 2016 Listed
Timeline
- Cleared FDA 510(k) K061853
- Listed FDA GUDID 00844505005708
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Precise Offset Total
- Generic name
- Ossicular prosthesis, total
- Model / reference
- 700-625
- Primary DI / UDI-DI
- 00844505005708
- 510(k) Number
- FDA product code
- ETA
- GMDN term
- Ossicular prosthesis, total
- Device class
- Class II
- Regulation number
- 874.3495
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional