510(k) K222515
K222515 is an FDA 510(k) premarket notification submitted by Dio Medical Corporation for the device "FaSet Fixation System". The FDA issued a decision of Substantially Equivalent on Oct 5, 2022. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Dio Medical Corporation has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2022
- Date Received
- Aug 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)