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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 K163038
Device Name EPIC Extremity Snap-Off Screw
Applicant
Epic Extremity, LLC
120 Marguerite Dr., Suite 301
Cranberry Twp,  PA  16066
Applicant Contact DAN SCHWARTZBAUER
Correspondent
Epic Extremity, LLC
1000 Hampton Center Suite A
Morgantown,  WV  26505
Correspondent Contact RANDY SCHLEMMER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/31/2016
Decision Date 02/28/2017
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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