Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem— 510(k) K220731

Substantially Equivalent

Stryker

FDA 510(k) clearance K220731 for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem, Substantially Equivalent on 2022-08-11. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2022-03-14
Decision date: 2022-08-11
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.