TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Acetabular Revision System Cemented Contrained Liner.

Pre-market Notification Details

Device IDK072121
510k NumberK072121
Device Name:TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactPatricia Jenks
CorrespondentPatricia Jenks
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-01
Decision Date2008-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024130333 K072121 000
00889024130258 K072121 000
00889024130265 K072121 000
00889024130272 K072121 000
00889024130289 K072121 000
00889024130296 K072121 000
00889024130302 K072121 000
00889024130319 K072121 000
00889024130326 K072121 000
00889024130241 K072121 000

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