Ali Interbody Fusion System— 510(k) K191516

Substantially Equivalent

Raed M. Ali, M.D., Inc.

FDA 510(k) clearance K191516 for Ali Interbody Fusion System, Substantially Equivalent on 2019-09-12. Applicant: Raed M. Ali, M.D., Inc..

Clearance details

Applicant: Raed M. Ali, M.D., Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2019-06-07
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Coast, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.