510(k) K030369 ยท NKB Thoracolumbosacral Pedicle Screw System
OPUS SPINAL SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | Feb 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030369
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.