Kyocera Bipolar Hip System— 510(k) K200709

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K200709 for Kyocera Bipolar Hip System, Substantially Equivalent on 2020-04-17. Applicant: Kyocera Medical Technologies, Inc..

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2020-03-18
Decision date: 2020-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.