K200491 is an FDA 510(k) clearance for the Bfix Orthopedic External Fixator Systems. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Aike (Shanghai) Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 5, 2021, 312 days after receiving the submission on February 28, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K200491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2020 |
| Decision Date | January 05, 2021 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |