510(k) K092929 ยท NKB Thoracolumbosacral Pedicle Screw System
SYNTHES MATRIX SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Dec 29, 2009 |
| Received | Sep 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092929
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2011 | Synthes USA (HQ), Inc. Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000.
Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.