510(k) K081597 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
| Applicant | Vertebron, Inc., Stratford CT, US |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | Jun 6, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081597
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.