510(k) K191494 · NKB Thoracolumbosacral Pedicle Screw System
Facilis Spinal System
| Applicant | Baui Biotech Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Aug 12, 2019 |
| Received | Jun 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191494
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.