FDA 510(k) Application Details - K230527

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K230527
Device Name	Plate, Fixation, Bone
Applicant	WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Kayla Johnston Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2023
Decision Date	03/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review