ProAM ALIF System— 510(k) K240126

Substantially Equivalent

Pro Surgical, Inc.

FDA 510(k) clearance K240126 for ProAM ALIF System, Substantially Equivalent on 2024-05-03. Applicant: Pro Surgical, Inc..

Clearance details

Applicant: Pro Surgical, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2024-01-16
Decision date: 2024-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Encinitas, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.