Cleared Special

AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM

K060209 · Tornier · Orthopedic

Mar 2006

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K060209 is an FDA 510(k) clearance for the AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on March 2, 2006, 34 days after receiving the submission on January 27, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K060209 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2006
Decision Date	March 02, 2006
Days to Decision	34 days
Submission Type	Special
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