Cleared Traditional

Exactech Equinoxe Humeral Augmented Trays

K191561 · Exactech, Inc. · Orthopedic

Aug 2019

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K191561 is an FDA 510(k) clearance for the Exactech Equinoxe Humeral Augmented Trays, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 20, 2019, 68 days after receiving the submission on June 13, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K191561 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2019
Decision Date	August 20, 2019
Days to Decision	68 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.