Evos 71175623
Evos 71175623 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K203405 on 27 Jan 2021 and listed in FDA GUDID since 19 May 2021 (UDI-DI 00885556765944), 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 | Number00885556765944 | Date19 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203405 | Date27 Jan 2021 | StatusActive |
Official records
- AccessGUDID record 00885556765944
- FDA 510(k) database K203405
Across registries
- FDA 510(k) K203405 decided 27 Jan 2021 Active
- FDA GUDID UDI-DI 00885556765944 listed 19 May 2021 Listed
Timeline
- Cleared FDA 510(k) K203405
- Listed FDA GUDID 00885556765944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Evos
- Generic name
- Surgical drill guide, reusable
- Model / Ref / Catalog
- 71175623
- Description
- EVOS LARGE 3.7MM SNAP IN NEUTRAL LOCKING HOLE DRILL GUIDE
- Primary DI / UDI-DI
- 00885556765944
- 510(k) Number
- FDA product code
- HRS
- GMDN term
- Surgical drill guide, reusable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization