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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 Interlaminal
510(k) Number K062181
Device Name C-JAWS CERVICAL COMPRESSIVE MINI FRAME
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 Number888.3050
Classification Product Code
KWP  
Date Received07/31/2006
Decision Date 01/16/2007
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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