510(k) K172175 · NKB Thoracolumbosacral Pedicle Screw System
CapSure® PS System
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Aug 16, 2017 |
| Received | Jul 19, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172175
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.