Saiph® 290-162
by Matortho
Saiph® 290-162 is a Class II device made by Matortho, cleared under FDA 510(k) K140222 on 17 Nov 2014 and listed in FDA GUDID since 18 Jan 2021 (UDI-DI 05055455517783), 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 | Number05055455517783 | Date18 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140222 | Date17 Nov 2014 | StatusActive |
Official records
- AccessGUDID record 05055455517783
- FDA 510(k) database K140222
Across registries
- FDA 510(k) K140222 decided 17 Nov 2014 Active
- FDA GUDID UDI-DI 05055455517783 listed 18 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K140222
- Listed FDA GUDID 05055455517783
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Saiph®
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 290-162
- Primary DI / UDI-DI
- 05055455517783
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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