510(k) K120354
K120354 is an FDA 510(k) premarket notification submitted by Skeletal Kinetics, LLC for the device "BETA-TCP GRANULES". The FDA issued a decision of Substantially Equivalent on March 21, 2013. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Skeletal Kinetics, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2013
- Date Received
- February 6, 2012
- 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