510(k) K232877
K232877 is an FDA 510(k) premarket notification submitted by K&J Consulting Corporation for the device "FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. K&J Consulting Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2023
- Date Received
- September 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type