K260571
- 510(k) number
- K260571
- Device name
- SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- Applicant
- Life Spine, Inc. IL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-06-02
- Date received
- 2026-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260571.pdf
Official FDA record: K260571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.