KMTI Hip Replacement System

Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

Kyocera Medical Technologies, Inc.

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

Pre-market Notification Details

Device IDK203472
510k NumberK203472
Device Name:KMTI Hip Replacement System
ClassificationHip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, 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 CodeOQG  
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeOQI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-25
Decision Date2021-04-02

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