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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
510(k) Number K182704
Device Name WishBone Guided Growth System
Applicant
Wishbone Medical
1250 N. Pt.e Dr.
Warsaw,  IN  46992
Applicant Contact Gary Barnett
Correspondent
Wishbone Medical
2150 N. Pt.e Dr.
Warsaw,  IN  46582
Correspondent Contact Mary Wetzel
Regulation Number888.3030
Classification Product Code
OBT  
Date Received09/27/2018
Decision Date 06/25/2019
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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