Cleared Traditional

Wrist Hemiarthroplasty System

K141920 · Arthrosurface, Inc. · Orthopedic
Dec 2014
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K141920 is an FDA 510(k) clearance for the Wrist Hemiarthroplasty System, a Prosthesis, Wrist, Carpal Lunate (Class II — Special Controls, product code KWN), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on December 23, 2014, 160 days after receiving the submission on July 16, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3750.

Submission Details

510(k) Number K141920 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2014
Decision Date December 23, 2014
Days to Decision 160 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWN — Prosthesis, Wrist, Carpal Lunate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3750