510(k) K190754
K190754 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Orthoss(R)". The FDA issued a decision of Substantially Equivalent on Jun 23, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Geistlich Pharma AG has 26 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2019
- Date Received
- Mar 25, 2019
- 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)