Cleared Traditional

Anatomical Shoulder Domelock Dome centric

K161620 · Zimmer GmbH · Orthopedic
Nov 2016
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K161620 is an FDA 510(k) clearance for the Anatomical Shoulder Domelock Dome centric, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on November 1, 2016, 141 days after receiving the submission on June 13, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K161620 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2016
Decision Date November 01, 2016
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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