DEPUY TOTAL ELBOW SYSTEM— 510(k) K992656

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K992656 for DEPUY TOTAL ELBOW SYSTEM, Substantially Equivalent on 1999-11-05. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code JDC
Advisory panel: Orthopedic
Date received: 1999-08-09
Decision date: 1999-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

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.