510(k) K240404
K240404 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Novabone Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2024
- Date Received
- February 9, 2024
- 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