510(k) K100952 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO SYNTHES MATRIX SYSTEM
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Aug 5, 2010 |
| Received | Apr 6, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2014 | Synthes (USA) Products LLC Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System.
Intended for posterior pedicle screw fixation Terminated |
NKB | None listed |
| 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.