510(k) K200062
K200062 is an FDA 510(k) premarket notification submitted by Leith Medical, LLC for the device "Foot and Ankle System". The FDA issued a decision of Substantially Equivalent on Feb 22, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2021
- Date Received
- Jan 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)