BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT— 510(k) K894604

Substantially Equivalent for Some Indications

Biopro, Inc.

FDA 510(k) clearance K894604 for BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT, Substantially Equivalent for Some Indications on 1989-11-17. Applicant: Biopro, Inc..

Clearance details

Applicant: Biopro, Inc.
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 1989-07-20
Decision date: 1989-11-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Port Huron, MI, US

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Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.