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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K172808
Device Name CosmoLock Pedicle Screw 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 Number888.3070
Classification Product Code
NKB  
Date Received09/18/2017
Decision Date 10/25/2017
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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