DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS— 510(k) K081917

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K081917 for DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS, Substantially Equivalent on 2009-05-22. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-07-03
Decision date: 2009-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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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.