510(k) K250346
K250346 is an FDA 510(k) premarket notification submitted by Elute, Inc. for the device "BonVie+". The FDA issued a decision of Substantially Equivalent on Feb 26, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Elute, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 2025
- Date Received
- Feb 6, 2025
- Clearance Type
- Special
- 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