FDA 510(k) Application Details - K214001

Device Classification Name	More FDA Info for this Device
510(K) Number	K214001
Device Name	Comprehensive« Shoulder System, Comprehensive« Reverse Shoulder System
Applicant	Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Aishwarya Pandey 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	12/21/2021
Decision Date	03/15/2023
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