510(k) K220360
K220360 is an FDA 510(k) premarket notification submitted by Microware Precision Co., Ltd. for the device "Tandry CMF Plate System". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Microware Precision Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2022
- Date Received
- February 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type