510(k) K233665
K233665 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System". The FDA issued a decision of Substantially Equivalent on March 21, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2024
- Date Received
- November 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type