EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt

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 - Exprt™ Hip Distal Stem, Exprt™ Hip Standard Offset Proximal Body Implant, Exprt™ Hip Lateral Offset Proximal Body Implant, Exprt™ Hip Capture Bolt.

Pre-market Notification Details

• Device ID: K163497
• 510k Number: K163497
• Device Name: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
• Classification: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC 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: 2016-12-13
• Decision Date: 2017-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190446324188	K163497	000
00190446324171	K163497	000
00190446324164	K163497	000
00190446153962	K163497	000
00190446153955	K163497	000
00190446153948	K163497	000
00190446153931	K163497	000
00190446153924	K163497	000
00190446153917	K163497	000