DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)— 510(k) K061648

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K061648 for DEPUY GRADUATED COMPARTMENTAL KNEE (GCK), Substantially Equivalent on 2006-09-11. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code NPJ
Advisory panel: Orthopedic
Date received: 2006-06-13
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code NPJ

product code NPJ

Injury: 258
Total: 258

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.