EXACTECH 12/14 TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech 12/14 Total Hip System.

Pre-market Notification Details

Device IDK041906
510k NumberK041906
Device Name:EXACTECH 12/14 TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville,  FL  32653
ContactGary J Miller
CorrespondentGary J Miller
EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville,  FL  32653
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-15
Decision Date2004-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10885862010872 K041906 000
10885862016799 K041906 000
10885862016805 K041906 000
10885862016812 K041906 000
10885862016829 K041906 000
10885862016836 K041906 000
10885862016843 K041906 000
10885862016973 K041906 000
10885862016980 K041906 000
10885862016997 K041906 000
10885862017000 K041906 000
10885862016782 K041906 000
10885862016775 K041906 000
10885862010889 K041906 000
10885862010896 K041906 000
10885862016690 K041906 000
10885862016706 K041906 000
10885862016713 K041906 000
10885862016720 K041906 000
10885862016737 K041906 000
10885862016744 K041906 000
10885862016751 K041906 000
10885862016768 K041906 000
10885862017017 K041906 000
10885862017024 K041906 000
10885862017031 K041906 000
10885862026828 K041906 000
10885862026835 K041906 000
10885862026842 K041906 000
10885862026859 K041906 000
10885862026866 K041906 000
10885862026880 K041906 000
10885862026897 K041906 000
10885862026903 K041906 000
10885862026910 K041906 000
10885862026927 K041906 000
10885862026804 K041906 000
10885862026798 K041906 000
10885862012449 K041906 000
10885862012456 K041906 000
10885862017239 K041906 000
10885862017246 K041906 000
10885862026729 K041906 000
10885862026736 K041906 000
10885862026743 K041906 000
10885862026750 K041906 000
10885862026774 K041906 000
10885862026781 K041906 000
10885862026941 K041906 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.