510(k) K202639
K202639 is an FDA 510(k) premarket notification submitted by Biostone, Ltd. for the device "si-Mochi". The FDA issued a decision of Substantially Equivalent on Apr 21, 2021. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 21, 2021
- Date Received
- Sep 11, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)