510(k) K130286 ยท NKB Thoracolumbosacral Pedicle Screw System
STREAMLINE MIS SPINAL FIXATION SYSTEM
| Applicant | Pioneer Surgical Technology, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Apr 1, 2013 |
| Received | Feb 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2014 | PIONEER SURGICAL TECHNOLOGY, INC. Streamline MIS Spinal Fixation System Fixed Rod Holder
NON STERILE, Rx only
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fi Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.