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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K193368
Device Name Smart Correction System
Applicant
Wishbone Medical, Inc.
2150 N. Pt.e Dr.
Warsaw,  IN  46582
Applicant Contact Mary Wentorf
Correspondent
Wishbone Medical, Inc.
2150 N. Pt.e Dr.
Warsaw,  IN  46582
Correspondent Contact Mary Wentorf
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received12/05/2019
Decision Date 09/18/2020
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
Recalls CDRH Recalls
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