BHR BIPOLAR FEMORAL HEAD COMPONENT— 510(k) K915528

Substantially Equivalent

Implantology Corp.

FDA 510(k) clearance K915528 for BHR BIPOLAR FEMORAL HEAD COMPONENT, Substantially Equivalent on 1993-06-29. Applicant: Implantology Corp..

Clearance details

Applicant: Implantology Corp.
Product code: Code LZY
Advisory panel: Orthopedic
Date received: 1991-12-10
Decision date: 1993-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pine Brook, NJ, US

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Adverse events under product code LZY

product code LZY

Injury: 431
Total: 431

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.