510(k) K021379 ยท MNI Orthosis, Spinal Pedicle Fixation
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
| Applicant | Ortho Tec, LLC, Chesterland OH, US |
| Decision | Substantially Equivalent, May 31, 2002 |
| Received | May 1, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021379
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.