510(k) K233368
K233368 is an FDA 510(k) premarket notification submitted by Bioventus, LLC for the device "Allograft Delivery Device (OFAC-C)". The FDA issued a decision of Substantially Equivalent on June 25, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bioventus, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2024
- Date Received
- October 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type