K233455
- 510(k) number
- K233455
- Device name
- ARx MIS Spinal Screw System
- Applicant
- Life Spine, Inc. IL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-12-12
- Date received
- 2023-10-20
- 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: K233455.pdf
Official FDA record: K233455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.