Cleared Traditional

EXPRT Revision Hip System

K161610 · Encore Medical, L.P. · Orthopedic

Nov 2016

Decision

152d

Days

Class 2

Risk

About This 510(k) Submission

K161610 is an FDA 510(k) clearance for the EXPRT Revision Hip System, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on November 9, 2016, 152 days after receiving the submission on June 10, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number	K161610 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2016
Decision Date	November 09, 2016
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3310