510(k) K190814
K190814 is an FDA 510(k) premarket notification submitted by Zimmer Knee Creations for the device "AccuFill Bone Substitute Material". The FDA issued a decision of Substantially Equivalent on Jun 10, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Zimmer Knee Creations has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 2019
- Date Received
- Mar 29, 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)