K240199
- 510(k) number
- K240199
- Device name
- IntraOp Alignment System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-05-22
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240199.pdf
Official FDA record: K240199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.