510(k) K140123 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
| Applicant | Ebi, LLC, Parsippany NJ, US |
| Decision | Substantially Equivalent, Apr 24, 2014 |
| Received | Jan 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2020 | Zimmer Biomet, Inc. Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.