UNIVERSAL SELF-ALIGNING ACETABULAR COM— 510(k) K834035

Substantially Equivalent

Orthopedic Equipment Co., Inc.

FDA 510(k) clearance K834035 for UNIVERSAL SELF-ALIGNING ACETABULAR COM, Substantially Equivalent on 1984-06-19. Applicant: Orthopedic Equipment Co., Inc..

Clearance details

Applicant: Orthopedic Equipment Co., Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1983-11-23
Decision date: 1984-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.