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 IDK163497
510k NumberK163497
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
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
ContactTeffany Hutto
CorrespondentTeffany Hutto
ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeKWZ  
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-13
Decision Date2017-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

Trademark Results [EXPRT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXPRT
EXPRT
88693932 not registered Live/Pending
Silva, Jenat M.
2019-11-15
EXPRT
EXPRT
87753910 not registered Dead/Abandoned
Silva, Jenat M.
2018-01-12
EXPRT
EXPRT
86594246 4862686 Live/Registered
Encore Medical, L.P.
2015-04-10
EXPRT
EXPRT
76496992 2805963 Dead/Cancelled
Icon Advertising & Design, Inc.
2003-03-13

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