FDA 510(k) Application Details - K170711

Device Classification Name	More FDA Info for this Device
510(K) Number	K170711
Device Name	ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
Applicant	Zimmer GmbH Sulzerallee 8 Winterthur 8404 CH Other 510(k) Applications for this Company
Contact	Roberto Tommasini 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	03/08/2017
Decision Date	06/01/2017
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