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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Passer, Wire, Orthopedic
510(k) Number K140576
Device Name Y WIRE 2
Applicant
Safewire, LLC
520 Butternut Dr., #8 Pmb#256
Holland,  MI  49424
Applicant Contact STEPHEN W INGLESE
Correspondent
Safewire, LLC
520 Butternut Dr., #8 Pmb#256
Holland,  MI  49424
Correspondent Contact STEPHEN W INGLESE
Regulation Number888.4540
Classification Product Code
HXI  
Date Received03/06/2014
Decision Date 05/20/2014
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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