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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 K143647
Device Name Renovis Surgical Hip Replacement System
Applicant
Renovis Surgical Technologies, Inc.
1901 W. Lugonia Ave., Suite 340
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 Received12/22/2014
Decision Date 05/11/2015
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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