510(k) K141253 ยท MNI Orthosis, Spinal Pedicle Fixation
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
| Applicant | New Era Orthopaedics, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Jan 9, 2015 |
| Received | May 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141253
| 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.