Arthrex Eclipse Shoulder Prosthesis System— 510(k) K183194

Name: FDA 510(k) clearance K183194
Creator: U.S. Food and Drug Administration
Published: 2019-07-26

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K183194 for Arthrex Eclipse Shoulder Prosthesis System, Substantially Equivalent on 2019-07-26. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code QHQ
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2018-11-19
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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