FDA 510(k) Application Details - K220717

Device Classification Name	More FDA Info for this Device
510(K) Number	K220717
Device Name	RedPoint Medical's Better Bunion System
Applicant	Redpoint Medical, LLC 13326 West Road Carmel, IN 46074 US Other 510(k) Applications for this Company
Contact	James Spitler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2022
Decision Date	06/09/2022
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