Cleared Special

HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System

K142942 · Arthrosurface, Inc. · Orthopedic
Dec 2014
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K142942 is an FDA 510(k) clearance for the HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on December 19, 2014, 66 days after receiving the submission on October 14, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K142942 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2014
Decision Date December 19, 2014
Days to Decision 66 days
Submission Type Special
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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