K241464
- 510(k) number
- K241464
- Device name
- ARx® SAI Implant System
- Applicant
- Life Spine, Inc. IL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-07-29
- Date received
- 2024-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241464.pdf
Official FDA record: K241464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.