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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K151553
Device Name Anterior Cervical Plate System
Applicant
Osteomed Implantes, Ltda
Washington Luiz Rd., Km 172, Condominio Conpark - Rua 6
Rio Claro - Sp,  BR 13501-600
Applicant Contact J.D. WEBB
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/09/2015
Decision Date 02/10/2016
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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