510(k) K111301 ยท NKB Thoracolumbosacral Pedicle Screw System
INSTINCT JAVA SYSTEM
| Applicant | Zimmer Spine, Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 26, 2011 |
| Received | May 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111301
| 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.