510(k) K200491
K200491 is an FDA 510(k) premarket notification submitted by Aike (Shanghai) Medical Instrument Co., Ltd. for the device "Bfix Orthopedic External Fixator Systems". The FDA issued a decision of Substantially Equivalent on Jan 5, 2021. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 2021
- Date Received
- Feb 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)