DEPUY ACE VERSANAIL TIBIAL NAIL

Rod, Fixation, Intramedullary And Accessories

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Ace Versanail Tibial Nail.

Pre-market Notification Details

Device IDK032097
510k NumberK032097
Device Name:DEPUY ACE VERSANAIL TIBIAL NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactTiffani Rogers
CorrespondentTiffani Rogers
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-08
Decision Date2003-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868018787 K032097 000
00887868018671 K032097 000
00887868018664 K032097 000
00887868018657 K032097 000
00887868018640 K032097 000
00887868018633 K032097 000
00887868018626 K032097 000
00887868018619 K032097 000
00887868018602 K032097 000
00887868018688 K032097 000
00887868018695 K032097 000
00887868018770 K032097 000
00887868018763 K032097 000
00887868018756 K032097 000
00887868018749 K032097 000
00887868018732 K032097 000
00887868018725 K032097 000
00887868018718 K032097 000
00887868018701 K032097 000
00887868018596 K032097 000
00887868018589 K032097 000
00887868018572 K032097 000
00887868018466 K032097 000
00887868018459 K032097 000
00887868018442 K032097 000
00887868018435 K032097 000
00887868018428 K032097 000
00887868018411 K032097 000
00887868018404 K032097 000
00887868018398 K032097 000
00887868018473 K032097 000
00887868018480 K032097 000
00887868018565 K032097 000
00887868018558 K032097 000
00887868018541 K032097 000
00887868018534 K032097 000
00887868018527 K032097 000
00887868018510 K032097 000
00887868018503 K032097 000
00887868018497 K032097 000
00887868018381 K032097 000
00887868019197 K032097 000
00887868019081 K032097 000
00887868019074 K032097 000
00887868019067 K032097 000
00887868019050 K032097 000
00887868019043 K032097 000
00887868019036 K032097 000
00887868019029 K032097 000
00887868019012 K032097 000
00887868019098 K032097 000
00887868019104 K032097 000
00887868019180 K032097 000
00887868019173 K032097 000
00887868019166 K032097 000
00887868019159 K032097 000
00887868019142 K032097 000
00887868019135 K032097 000
00887868019128 K032097 000
00887868019111 K032097 000
00887868019005 K032097 000
00887868018992 K032097 000
00887868018985 K032097 000
00887868018879 K032097 000
00887868018862 K032097 000
00887868018855 K032097 000
00887868018848 K032097 000
00887868018831 K032097 000
00887868018824 K032097 000
00887868018817 K032097 000
00887868018800 K032097 000
00887868018886 K032097 000
00887868018893 K032097 000
00887868018978 K032097 000
00887868018961 K032097 000
00887868018954 K032097 000
00887868018947 K032097 000
00887868018930 K032097 000
00887868018923 K032097 000
00887868018916 K032097 000
00887868018909 K032097 000
00887868018794 K032097 000

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