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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K132312
Device Name RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
Applicant
Renovis Surgical Technologies, LLC
200 Homer Ave.,
Ashland,  MA  01721
Applicant Contact Sharyn Orton, Ph.D.
Correspondent
Renovis Surgical Technologies, LLC
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Sharyn Orton, Ph.D.
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/25/2013
Decision Date 04/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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