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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 K153638
Device Name Bicortical Fixation Screw & Washer Nut System
Applicant
First Ray, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Applicant Contact ROBERT HOY
Correspondent
First Ray, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Correspondent Contact ROBERT HOY
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received12/18/2015
Decision Date 04/19/2016
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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