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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, Cemented
510(k) Number K141370
Device Name RENOVIS CEMENTED HIP SYSTEM
Applicant
Renovis Surgical Technologies, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Applicant Contact Sharyn Orton
Correspondent
Renovis Surgical Technologies, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/27/2014
Decision Date 09/02/2014
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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