CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES— 510(k) K822979

Substantially Equivalent

Allo Pro Corp.

FDA 510(k) clearance K822979 for CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES, Substantially Equivalent on 1983-01-14. Applicant: Allo Pro Corp..

Clearance details

Applicant: Allo Pro Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1982-10-08
Decision date: 1983-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.