510(k) K131365 ยท HSB Rod, Fixation, Intramedullary And Accessories
T2 TIBIAL NAILING SYSTEM
| Applicant | Stryker Trauma AG, Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2013 |
| Received | May 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2021 | Stryker GmbH Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S Open, Classified |
HSB | None listed |
| May 27, 2021 | Stryker GmbH Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S Open, Classified |
HSB | None listed |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | None listed |
| Oct 14, 2014 | Stryker Howmedica Osteonics Corp. Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13.
Product Usage:
The T2 Tibial Nailing system is intended to provide temp Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.