510(k) K123552 ยท NKB Thoracolumbosacral Pedicle Screw System
INSTINCT JAVA SYSTEM
| Applicant | Zimmer Spine, Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 19, 2013 |
| Received | Nov 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Zimmer Spine, Inc. Instinct Java System (IFU reference: 046WAN0000T) .
Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.