FDA 510(k) Application Details - K203375

Device Classification Name	More FDA Info for this Device
510(K) Number	K203375
Device Name	OVOMotion Reverse Shoulder Arthroplasty System
Applicant	Arthrosurface Inc. 28 Forge Parkway Franklin, ME 02038 US Other 510(k) Applications for this Company
Contact	Dawn J. Wilson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2020
Decision Date	06/24/2021
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