510(k) K092128 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO: PSS SYSTEM
| Applicant | Spinal USA, Pear MS, US |
| Decision | Substantially Equivalent, Sep 14, 2009 |
| Received | Jul 15, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092128
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.