K251644
- 510(k) number
- K251644
- Device name
- ProAM ALIF System
- Applicant
- Pro Surgical, Inc. CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-06-24
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251644.pdf
Official FDA record: K251644
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.