510(k) K102413 ยท HSB Rod, Fixation, Intramedullary And Accessories
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
| Applicant | Vilex, Inc., Mcminnville TN, US |
| Decision | Substantially Equivalent, Nov 14, 2011 |
| Received | Aug 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | None listed |
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | None listed |
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.