Evos 72463208N
Evos 72463208N is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K213126 on 29 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00885556642825), 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 | FDA 510(k)SESE | NumberK213126 | Date29 Sep 2022 | StatusActive |
| United States | GUDID listing | Number00885556642825 | Date22 Aug 2017 | StatusListed |
Official records
- AccessGUDID record 00885556642825
- FDA 510(k) database K213126
- FDA 510(k) database K210837
- FDA 510(k) database K170457
Across registries
- FDA 510(k) K213126 decided 29 Sep 2022 Active
- FDA GUDID UDI-DI 00885556642825 listed 22 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K170457
- Listed FDA GUDID 00885556642825
- Cleared FDA 510(k) K210837
- Cleared FDA 510(k) K213126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Evos
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable
- Model / Ref / Catalog
- 72463208N
- Primary DI / UDI-DI
- 00885556642825
- FDA product code
- HRS
- GMDN term
- Orthopaedic fixation plate, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
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