Catalyst CSR Shoulder System— 510(k) K152825

Substantially Equivalent

Catalyst Orthoscience, LLC

FDA 510(k) clearance K152825 for Catalyst CSR Shoulder System, Substantially Equivalent on 2016-05-11. Applicant: Catalyst Orthoscience, LLC.

Clearance details

Applicant: Catalyst Orthoscience, LLC
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2015-09-29
Decision date: 2016-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.