K232877
- 510(k) number
- K232877
- Device name
- FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System
- Applicant
- K&J Consulting Corporation PA · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2023-12-13
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232877.pdf
Official FDA record: K232877
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.