510(k) K150647 ยท MNI Orthosis, Spinal Pedicle Fixation
Polyscrew Pedicle Screw System
| Applicant | New Era Orthopedics, LLC, Hummelstown PA, US |
| Decision | Substantially Equivalent, Apr 8, 2015 |
| Received | Mar 12, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2017 | New Era Orthopaedics, LLc Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.