Tfcc Fast-Fix Kit
510(k) K132079
Tfcc Fast-Fix Kit is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K132079 on 5 Dec 2013, active as of 22 Oct 2026. One FDA recall is 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 | NumberK132079 | Date5 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K132079
Recalls
-
- Terminated Z-1822-2015
Sterility of device maybe compromised
Timeline
- Cleared FDA 510(k) K132079
- Recall initiated FDA recalls Z-1822-2015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GAT
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132079
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FAST-FIX 72203986 | 72203986 / 72203986 | 00885554032154 | — | On the market |
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