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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 K102406
Device Name PASS ANTERIOR SPINAL SYSTEM
Applicant
Medicrea Technologies
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J D WEBB
Correspondent
Medicrea Technologies
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J D WEBB
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/24/2010
Decision Date 08/23/2011
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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