MONDRIAN Lumbar Interbody Fusion Cage System— 510(k) K192863

Substantially Equivalent

Ctl Medical Corporation

FDA 510(k) clearance K192863 for MONDRIAN Lumbar Interbody Fusion Cage System, Substantially Equivalent on 2020-08-26. Applicant: Ctl Medical Corporation.

Clearance details

Applicant: Ctl Medical Corporation
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2019-10-07
Decision date: 2020-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.