FDA 510(k) Application Details - K182516

Device Classification Name	More FDA Info for this Device
510(K) Number	K182516
Device Name	Comprehensive Nano Stemless Shoulder
Applicant	Biomet Manufacturing Corp 56 East Bell Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Jeff Gensler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2018
Decision Date	04/22/2019
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