Insignia Hip Stem— 510(k) K211703

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K211703 for Insignia Hip Stem, Substantially Equivalent on 2021-08-16. Applicant: Stryker Orthopaedics.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2021-06-03
Decision date: 2021-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.