510(k) K200064
K200064 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft". The FDA issued a decision of Substantially Equivalent on Aug 14, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. SurGenTec, LLC has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2020
- Date Received
- Jan 13, 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)