Exactech® Novation® Element Press-fit Femoral Stem

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

EXACTECH INC

The following data is part of a premarket notification filed by Exactech Inc with the FDA for Exactech® Novation® Element Press-fit Femoral Stem.

Pre-market Notification Details

Device IDK153649
510k NumberK153649
Device Name:Exactech® Novation® Element Press-fit Femoral Stem
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant EXACTECH INC 2320 NW 66TH COURT Gainesville,  FL  32653
ContactThomas Mcnamara
CorrespondentThomas Mcnamara
EXACTECH INC 2320 NW 66TH COURT Gainesville,  FL  32653
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-08-31
Summary:summary

Trademark Results [Exactech]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXACTECH
EXACTECH
97543105 not registered Live/Pending
Exactech, Inc.
2022-08-10
EXACTECH
EXACTECH
86168270 not registered Dead/Abandoned
Tyco Fire & Security GMBH
2014-01-17
EXACTECH
EXACTECH
79175410 4990914 Live/Registered
Tyco Fire & Security GmbH
2015-08-09
EXACTECH
EXACTECH
77792130 3877806 Live/Registered
Exactech, Inc.
2009-07-29
EXACTECH
EXACTECH
77792119 3868433 Live/Registered
Exactech, Inc.
2009-07-29
EXACTECH
EXACTECH
77350327 not registered Dead/Abandoned
Abbott Laboratories
2007-12-12
EXACTECH
EXACTECH
75132151 2115548 Dead/Cancelled
Medisense, Inc.
1996-07-10
EXACTECH
EXACTECH
73804174 1650672 Dead/Cancelled
EXACTECH, INC.
1989-06-01
EXACTECH
EXACTECH
73713884 1509981 Dead/Cancelled
BAXTER TRAVENOL LABORATORIES, INC.
1988-02-29
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