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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K080259
Device Name JMEA CANNULATED BONE SCREW SYSTEM
Applicant
Jmea Corporation
1 Research Court, Suite 450
Rockville,  MD  20850
Applicant Contact SAM SON
Correspondent
Jmea Corporation
1 Research Court, Suite 450
Rockville,  MD  20850
Correspondent Contact SAM SON
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received01/31/2008
Decision Date 08/20/2008
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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