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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 K203467
Device Name WishBone Medical Plate and Screw System
Applicant
Wishbone Medical, Inc.
100 Capital Dr.
Warsaw,  IN  46582
Applicant Contact Mary Wentorf
Correspondent
Wishbone Medical, Inc.
100 Capital Dr.
Warsaw,  IN  46582
Correspondent Contact Mary Wentorf
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received11/25/2020
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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