510(k) K200491 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Bfix Orthopedic External Fixator Systems
| Applicant | Aike (Shanghai) Medical Instrument Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jan 5, 2021 |
| Received | Feb 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200491
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.