EXPRT Revision Hip System

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

Encore Medical, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Exprt Revision Hip System.

Pre-market Notification Details

• Device ID: K161610
• 510k Number: K161610
• Device Name: EXPRT Revision Hip System
• Classification: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
• Applicant: Encore Medical, L.P. 9800 METIRC BLVD Austin, TX 78758
• Contact: Teffany Hutto
• Correspondent: Teffany Hutto; Encore Medical, L.P. 9800 METRIC BLVD Austin, TX 78758
• Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-10
• Decision Date: 2016-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190446155683	K161610	000
00190446154037	K161610	000
00190446154044	K161610	000
00190446154051	K161610	000
00190446154068	K161610	000
00190446154075	K161610	000
00190446154082	K161610	000
00190446154099	K161610	000
00190446154105	K161610	000
00190446154112	K161610	000
00190446154129	K161610	000
00190446154136	K161610	000
00190446154143	K161610	000
00190446154150	K161610	000
00190446154167	K161610	000
00190446154174	K161610	000
00190446154181	K161610	000
00190446154020	K161610	000
00190446154013	K161610	000
00190446154006	K161610	000
00190446155751	K161610	000
00190446155768	K161610	000
00190446155737	K161610	000
00190446155744	K161610	000
00190446155782	K161610	000
00190446155690	K161610	000
00190446155713	K161610	000
00190446153818	K161610	000
00190446153825	K161610	000
00190446153832	K161610	000
00190446153849	K161610	000
00190446153856	K161610	000
00190446153863	K161610	000
00190446153979	K161610	000
00190446153986	K161610	000
00190446153993	K161610	000
00190446154198	K161610	000
00190446154204	K161610	000
00190446155959	K161610	000
00190446155966	K161610	000
00190446155973	K161610	000
00190446155980	K161610	000
00190446155997	K161610	000
00190446156000	K161610	000
00190446156017	K161610	000
00190446156024	K161610	000
00190446156031	K161610	000
00190446156048	K161610	000
00190446164678	K161610	000
00190446164685	K161610	000
00190446164692	K161610	000
00190446191469	K161610	000
00190446191476	K161610	000
00190446212249	K161610	000
00190446155942	K161610	000
00190446155935	K161610	000
00190446155928	K161610	000
00190446155706	K161610	000
00190446155720	K161610	000
00190446155775	K161610	000
00190446155799	K161610	000
00190446155805	K161610	000
00190446155812	K161610	000
00190446155829	K161610	000
00190446155836	K161610	000
00190446155843	K161610	000
00190446155850	K161610	000
00190446155867	K161610	000
00190446155874	K161610	000
00190446155881	K161610	000
00190446155898	K161610	000
00190446155904	K161610	000
00190446155911	K161610	000
00190446212256	K161610	000