510(k) K152132 ยท MNI Orthosis, Spinal Pedicle Fixation
X-spine Pedicle Screw System
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Sep 25, 2015 |
| Received | Jul 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2026 | XTANT Medical Holdings, Inc XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. Open, Classified |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.