510(k) K192396 ยท NKB Thoracolumbosacral Pedicle Screw System
Streamline MIS Spinal Fixation System
| Applicant | Pioneer Surgical Technology, Inc., Marquette MI, US |
| Decision | Substantially Equivalent, Nov 26, 2019 |
| Received | Sep 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192396
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.