Evos 72402434
Evos 72402434 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 21 Sep 2015 (UDI-DI 00885556428542), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213126 | Date29 Sep 2022 | StatusActive |
| United States | GUDID listing | Number00885556428542 | Date21 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 00885556428542
- FDA 510(k) database K213126
- FDA 510(k) database K210837
- FDA 510(k) database K140814
Across registries
- FDA 510(k) K213126 decided 29 Sep 2022 Active
- FDA GUDID UDI-DI 00885556428542 listed 21 Sep 2015 Listed
Recalls
-
- Terminated Z-2945-2020
Multiple or incorrect expiration dates were provided on the affected designation labels.
-
- Terminated Z-0408-2018
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Timeline
- Cleared FDA 510(k) K140814
- Listed FDA GUDID 00885556428542
- Recall initiated FDA recalls Z-0408-2018
- Recall initiated FDA recalls Z-2945-2020
- 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- Withdrawn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 bone screw (non-sliding)
- Model / Ref / Catalog
- 72402434
- Primary DI / UDI-DI
- 00885556428542
- FDA product code
- HRS
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 34 Millimeter
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