AEGIS ANTERIOR LUMBAR PLATE SYSTEM— 510(k) K052546

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K052546 for AEGIS ANTERIOR LUMBAR PLATE SYSTEM, Substantially Equivalent on 2006-02-03. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2005-09-16
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.