498.805
by Synthes GmbH
498.805 (498805) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K992617 on 27 Oct 1999 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 20886982236965), active as of 12 Nov 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 | Number20886982236965 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992617 | Date27 Oct 1999 | StatusActive |
Official records
- AccessGUDID record 20886982236965
- FDA 510(k) database K992617
Across registries
- FDA 510(k) K992617 decided 27 Oct 1999 Active
- FDA GUDID UDI-DI 20886982236965 listed 14 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K992617
- Listed FDA GUDID 20886982236965
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Implantable orthopaedic/craniofacial device connection screw
- Model / Ref / Catalog
- 498.805, 498805
- Primary DI / UDI-DI
- 20886982236965
- 510(k) Number
- FDA product code
- HTN
- GMDN term
- Implantable orthopaedic/craniofacial device connection screw
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Implantable orthopaedic/craniofacial device connection screw.