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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 K121417
Device Name XMCP, HALLUX, TARSX, 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 Received05/11/2012
Decision Date 07/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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