510(k) K171161
K171161 is an FDA 510(k) premarket notification submitted by Dimensional Bioceramics, LLC for the device "Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)". The FDA issued a decision of Substantially Equivalent on September 25, 2017. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Dimensional Bioceramics, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2017
- Date Received
- April 20, 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