BIOPRO METAL BACKED CEMENTED ACETABULAR CUP— 510(k) K910352

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K910352 for BIOPRO METAL BACKED CEMENTED ACETABULAR CUP, Substantially Equivalent on 1991-06-13. Applicant: Biopro, Inc..

Clearance details

Applicant: Biopro, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1991-01-29
Decision date: 1991-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, 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.