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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K200328
Device Name Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Applicant
Kyocera Medical Technologies, Inc.
1200 California St.
Suite 210
Redlands,  CA  92374
Applicant Contact Anthony DeBenedictis
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
LPH   LZO   OQI  
Date Received02/10/2020
Decision Date 03/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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