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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K173013
Device Name WishBone K-Wire System
Applicant
Wishbone Medical, Inc.
2150 N. Pt.e Dr.
Warsaw,  IN  46582
Applicant Contact Gary Barnett
Correspondent
Wishbone Medical, Inc.
2150 N. Pt.e Dr.
Warsaw,  IN  46582
Correspondent Contact Gary Barnett
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/27/2017
Decision Date 12/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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