Cleared Traditional

AEQUALIS REVERSED ADAPTER

K071948 · Tornier · Orthopedic

Oct 2007

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K071948 is an FDA 510(k) clearance for the AEQUALIS REVERSED ADAPTER, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on October 18, 2007, 97 days after receiving the submission on July 13, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K071948 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2007
Decision Date	October 18, 2007
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.