510(k) K133746 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Mar 12, 2014 |
| Received | Dec 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2015 | Biomet Spine, LLC Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.