510(k) K193075
K193075 is an FDA 510(k) premarket notification submitted by Sirakoss , Ltd. for the device "Osteo3 ZP Putty". The FDA issued a decision of Substantially Equivalent on Jun 9, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 9, 2020
- Date Received
- Nov 4, 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)