KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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, Tesera Trabecular Technologies (t3) Acetabular Shell System, Porous Acetabular Cup System.

Pre-market Notification Details

Device IDK201660
510k NumberK201660
Device Name:KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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 Received2020-06-18
Decision Date2020-07-16

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