Arthrex Eclipse Shoulder Prosthesis System— 510(k) K201542

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K201542 for Arthrex Eclipse Shoulder Prosthesis System, Substantially Equivalent on 2020-07-08. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code PKC
Advisory panel: Orthopedic
Date received: 2020-06-09
Decision date: 2020-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.