CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

ZIMMER GMBH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Cls Brevius Stem With Kinectiv Technology.

Pre-market Notification Details

Device IDK110836
510k NumberK110836
Device Name:CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactDaniel J Williman
CorrespondentDaniel J Williman
ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeKWA  
Subsequent Product CodeJDI
Subsequent Product CodeJDL
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-25
Decision Date2011-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024134522 K110836 000
00889024134973 K110836 000
00889024134966 K110836 000
00889024134959 K110836 000
00889024134942 K110836 000
00889024134935 K110836 000
00889024134928 K110836 000
00889024134911 K110836 000
00889024134904 K110836 000
00889024134898 K110836 000
00889024134881 K110836 000
00889024134874 K110836 000
00889024134867 K110836 000
00889024134812 K110836 000
00889024134805 K110836 000
00889024134799 K110836 000
00889024134980 K110836 000
00889024134997 K110836 000
00889024135000 K110836 000
00889024135178 K110836 000
00889024135154 K110836 000
00889024135130 K110836 000
00889024135123 K110836 000
00889024135116 K110836 000
00889024135109 K110836 000
00889024135093 K110836 000
00889024135086 K110836 000
00889024135079 K110836 000
00889024135062 K110836 000
00889024135055 K110836 000
00889024135048 K110836 000
00889024135031 K110836 000
00889024135024 K110836 000
00889024135017 K110836 000
00889024134782 K110836 000

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