Arthrex Eclipse Titanium Humeral Head— 510(k) K203100

Name: FDA 510(k) clearance K203100
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K203100 for Arthrex Eclipse Titanium Humeral Head, Substantially Equivalent on 2020-11-20. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2020-10-14
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20

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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.