Zimmer, Inc. Hip Joint Prostheses MR Labeling I

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer, Inc. Hip Joint Prostheses Mr Labeling I.

Pre-market Notification Details

Device IDK200823
510k NumberK200823
Device Name:Zimmer, Inc. Hip Joint Prostheses MR Labeling I
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant Zimmer, Inc. P.O. Box 708 Warsaw,  IN  46861 -0708
ContactCaleb Barylski
CorrespondentCaleb Barylski
Zimmer, Inc. P.O. Box 708 Warsaw,  IN  46861 -0708
Product CodeJDI  
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-07-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.