510(k) K170917
K170917 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials for the device "Bi-Ostetic Bioactive Glass Foam". The FDA issued a decision of Substantially Equivalent on Oct 30, 2017. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 2017
- Date Received
- Mar 29, 2017
- 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)