510(k) K113044 ยท NKB Thoracolumbosacral Pedicle Screw System
SYNTHES MIRS
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Oct 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2013 | Synthes USA HQ, Inc. Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500
Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior h Terminated |
NKB | None listed |
| Nov 26, 2013 | Synthes USA HQ, Inc. Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502
Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixat Terminated |
NKB | None listed |
| Oct 1, 2012 | Synthes USA HQ, Inc. MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine.
The Synthes USS are non-cervial spinal fixation devices intended Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.