Cleared Traditional

MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM

K043077 · Tornier · Orthopedic

Dec 2004

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K043077 is an FDA 510(k) clearance for the MODIFICATION TO 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 (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on December 17, 2004, 39 days after receiving the submission on November 8, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K043077 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2004
Decision Date	December 17, 2004
Days to Decision	39 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