HELFET ELBOW PROSTHESIS— 510(k) K802460

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K802460 for HELFET ELBOW PROSTHESIS, Substantially Equivalent on 1980-11-19. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 1980-10-08
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.