510(k) K053276 ยท NKB Thoracolumbosacral Pedicle Screw System
IST PEDICLE SCREW SYSTEM
| Applicant | Innovative Spinal Technologies, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Dec 27, 2005 |
| Received | Nov 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053276
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.