iNSitu Bipolar Hip System— 510(k) K191297

Substantially Equivalent

Theken Companies, LLC

FDA 510(k) clearance K191297 for iNSitu Bipolar Hip System, Substantially Equivalent on 2019-09-17. Applicant: Theken Companies, LLC.

Clearance details

Applicant: Theken Companies, LLC
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2019-05-14
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.