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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 K170342
Device Name Ocata Anterior Cervical System
Applicant
Kalitec Direct, LLC
618 E. S. St., Suite 500
Orlando,  FL  32801
Applicant Contact Scott Winn
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 Received02/03/2017
Decision Date 05/09/2017
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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