510(k) K123549 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Feb 25, 2013 |
| Received | Nov 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2015 | Ebi, Llc Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the de Terminated |
NKB | None listed |
| Nov 19, 2013 | Ebi, Llc BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile.
Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.