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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 K130652
Device Name VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
Applicant
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Applicant Contact MATTHEW HULL
Correspondent
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Correspondent Contact MATTHEW HULL
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   KWL   KWY   LPH   LWJ  
LZO   OQH   OQI  
Date Received03/12/2013
Decision Date 12/17/2013
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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