Cleared Traditional

GRS GLENOID RESURFACING SYSTEM

K091196 · Arthrosurface, Inc. · Orthopedic

Oct 2009

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

K091196 is an FDA 510(k) clearance for the GRS GLENOID RESURFACING SYSTEM, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on October 27, 2009, 187 days after receiving the submission on April 23, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K091196 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2009
Decision Date	October 27, 2009
Days to Decision	187 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660