Evos 72402723N
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213126 | Date29 Sep 2022 | StatusActive |
| United States | GUDID listing | Number00885556450246 | Date21 Sep 2015 | StatusListed |
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.
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- Withdrawn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
- 72402723N
- Primary DI / UDI-DI
- 00885556450246
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
Other devices from Smith & Nephew, Inc.
Properties
Other properties (10)
- Supplied sterile: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No