Cleared Special

Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap

K182536 · Exactech, Inc. · Orthopedic

Oct 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K182536 is an FDA 510(k) clearance for the Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap, 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 October 12, 2018, 28 days after receiving the submission on September 14, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K182536 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2018
Decision Date	October 12, 2018
Days to Decision	28 days
Submission Type	Special
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.