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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 K093770
Device Name EXTREMITY MEDICAL SCREW SYSTEM
Applicant
Extremity Medical, LLC
300 Interpace Pkwy.
Suite 410
Parsippany,  NJ  07054
Applicant Contact JAMY GANNOE
Correspondent
Extremity Medical, LLC
300 Interpace Pkwy.
Suite 410
Parsippany,  NJ  07054
Correspondent Contact JAMY GANNOE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/08/2009
Decision Date 04/28/2010
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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