Smart Tsf 71075113B
Smart Tsf 71075113B is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K210953 on 29 Jul 2021 and listed in FDA GUDID since 10 Aug 2021 (UDI-DI 00885556799789), 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 | Number00885556799789 | Date10 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210953 | Date29 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00885556799789
- FDA 510(k) database K210953
Across registries
- FDA 510(k) K210953 decided 29 Jul 2021 Active
- FDA GUDID UDI-DI 00885556799789 listed 10 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K210953
- Listed FDA GUDID 00885556799789
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smart Tsf
- Generic name
- External orthopaedic fixation system, single-use
- Model / Ref / Catalog
- 71075113B
- Primary DI / UDI-DI
- 00885556799789
- 510(k) Number
- FDA product code
- KTT
- GMDN term
- External orthopaedic fixation system, single-use
- 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
Similar devices in this category
Other devices filed under External orthopaedic fixation system, single-use.