Gamma4 System— 510(k) K230512

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K230512 for Gamma4 System, Substantially Equivalent on 2023-06-09. Applicant: Stryker GmbH.

Clearance details

Applicant: Stryker GmbH
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2023-02-24
Decision date: 2023-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.