510(k) K201781
K201781 is an FDA 510(k) premarket notification submitted by Zavation Medical Products, LLC for the device "Uni-FuZe-P Bone Putty". The FDA issued a decision of Substantially Equivalent on December 28, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Zavation Medical Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2020
- Date Received
- June 30, 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