510(k) K062685 ยท NKB Thoracolumbosacral Pedicle Screw System
EBI ARAY SPINAL SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 6, 2006 |
| Received | Sep 8, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2010 | Ebi, Llc ARRAY and POLARIS Spinal System Medium Cross Connector
Non Sterile
Biomet Spine, Parsippany, NJ. 07054 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.