FDA 510(k) Application Details - K182704

Device Classification Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis   More FDA Info for this Device
510(K) Number	K182704
Device Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Applicant	WishBone Medical 1250 North Pointe Drive Warsaw, IN 46992 US Other 510(k) Applications for this Company
Contact	Gary Barnett Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	OBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2018
Decision Date	06/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review