Cleared Traditional

AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS

K082120 · Tornier · Orthopedic

Oct 2008

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K082120 is an FDA 510(k) clearance for the AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS, 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 October 24, 2008, 88 days after receiving the submission on July 28, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K082120 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2008
Decision Date	October 24, 2008
Days to Decision	88 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