510(k) K171497 ยท MNI Orthosis, Spinal Pedicle Fixation
Mikron Spinal Fixation System
| Applicant | Mikron Makina Sanayi Ticaret Co. , Ltd., Ankara, TR |
| Decision | Substantially Equivalent, Oct 12, 2017 |
| Received | May 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171497
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.