510(k) K212627 ยท NKB Thoracolumbosacral Pedicle Screw System
True Tulip, True M.I.S.
| Applicant | Innovative Surgical Designs, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Feb 18, 2022 |
| Received | Aug 19, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212627
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.