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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 K153333
Device Name Epic Extremity Cannulated Screw System
Applicant
Epic Extremity, LLC
120 Marguerite Dr., Suite 301
Cranberry Twp,  PA  16066
Applicant Contact Dan Schwartzbauer
Correspondent
Intrepid Orthopedics, LLC
3046 Brecksville Rd.
Suite 4
Richfield,  OH  44286
Correspondent Contact Lee Strnad
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/19/2015
Decision Date 01/19/2016
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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