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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 K102343
Device Name EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
Applicant
Emerge Medical
80 Shelton Technology Center
Shelton,  CO  80202
Applicant Contact CURTIS RAYMOND
Correspondent
Emerge Medical
80 Shelton Technology Center
Shelton,  CO  80202
Correspondent Contact CURTIS RAYMOND
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/17/2010
Decision Date 11/23/2010
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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