Kyocera Bipolar Hip System

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Kyocera Medical Technologies, Inc.

The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Kyocera Bipolar Hip System.

Pre-market Notification Details

Device IDK200709
510k NumberK200709
Device Name:Kyocera Bipolar Hip System
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant Kyocera Medical Technologies, Inc. 1200 California St Suite 210 Redlands,  CA  92374
ContactAnthony Debenedictis
CorrespondentSharyn Orton
MEDIcept, Inc. 200 Homer Ave Ashland,  MA  01721
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2020-04-17

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