ZIMMER NEXEL TOTAL ELBOW

Prosthesis, Elbow, Constrained, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Nexel Total Elbow.

Pre-market Notification Details

Device IDK123862
510k NumberK123862
Device Name:ZIMMER NEXEL TOTAL ELBOW
ClassificationProsthesis, Elbow, Constrained, Cemented
Applicant ZIMMER, INC. 1800 WEST CENTER STREET Warsaw,  IN  46580
ContactJoanna L Surma
CorrespondentJoanna L Surma
ZIMMER, INC. 1800 WEST CENTER STREET Warsaw,  IN  46580
Product CodeJDC  
CFR Regulation Number888.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-14
Decision Date2013-03-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024272019 K123862 000
00889024271876 K123862 000
00889024271869 K123862 000
00889024271852 K123862 000
00889024271845 K123862 000
00889024271838 K123862 000
00889024271821 K123862 000
00889024271814 K123862 000
00889024271807 K123862 000
00889024271791 K123862 000
00889024271784 K123862 000
00889024271883 K123862 000
00889024271890 K123862 000
00889024271906 K123862 000
00889024272002 K123862 000
00889024271999 K123862 000
00889024271982 K123862 000
00889024271975 K123862 000
00889024271968 K123862 000
00889024271951 K123862 000
00889024271944 K123862 000
00889024271937 K123862 000
00889024271920 K123862 000
00889024271913 K123862 000
00889024271777 K123862 000
00889024271760 K123862 000
00889024271623 K123862 000
00889024271616 K123862 000
00889024271609 K123862 000
00889024271593 K123862 000
00889024271586 K123862 000
00889024271579 K123862 000
00889024271562 K123862 000
00889024271555 K123862 000
00889024271548 K123862 000
00889024271531 K123862 000
00889024271630 K123862 000
00889024271647 K123862 000
00889024271654 K123862 000
00889024271753 K123862 000
00889024271746 K123862 000
00889024271739 K123862 000
00889024271722 K123862 000
00889024271715 K123862 000
00889024271708 K123862 000
00889024271692 K123862 000
00889024271685 K123862 000
00889024271678 K123862 000
00889024271661 K123862 000
70889024589529 K123862 000
00889024271463 K123862 000
00889024271326 K123862 000
00889024271319 K123862 000
00889024271302 K123862 000
00889024271296 K123862 000
00889024271289 K123862 000
00889024271272 K123862 000
00889024271265 K123862 000
00889024271258 K123862 000
00889024271241 K123862 000
00889024271234 K123862 000
00889024271333 K123862 000
00889024271340 K123862 000
00889024271357 K123862 000
00889024271456 K123862 000
00889024271449 K123862 000
00889024271432 K123862 000
00889024271425 K123862 000
00889024271418 K123862 000
00889024271401 K123862 000
00889024271395 K123862 000
00889024271388 K123862 000
00889024271371 K123862 000
00889024271364 K123862 000
00889024271227 K123862 000
00887868226991 K123862 000
00889024272125 K123862 000
00889024272118 K123862 000
00889024272101 K123862 000
00889024272095 K123862 000
00889024272088 K123862 000
00889024272071 K123862 000
00889024272064 K123862 000
00889024272057 K123862 000
00889024272040 K123862 000
00889024272033 K123862 000
00889024272132 K123862 000
00889024272149 K123862 000
00889024272156 K123862 000
00889024272255 K123862 000
00889024272248 K123862 000
00889024272231 K123862 000
00889024272224 K123862 000
00889024272217 K123862 000
00889024272200 K123862 000
00889024272194 K123862 000
00889024272187 K123862 000
00889024272170 K123862 000
00889024272163 K123862 000
00889024272026 K123862 000

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