510(k) K221745 ยท NKB Thoracolumbosacral Pedicle Screw System
Sterile Posterior Spinal Fixation System
| Applicant | Shanghai Reach Medical Instrument Co, Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Aug 31, 2022 |
| Received | Jun 16, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221745
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.