K232605
- 510(k) number
- K232605
- Device name
- Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
- Applicant
- Lesspine Innovations MA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2023-09-28
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232605.pdf
Official FDA record: K232605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.