510(k) K151592 ยท MNI Orthosis, Spinal Pedicle Fixation
Gemmed pedicle screw spinal system
| Applicant | Suzhou Gemmed Medical Instrument Co., Ltd., Zhangjiagang City, CN |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Jun 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151592
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.