FDA 510(k) Application Details - K211553

Device Classification Name	More FDA Info for this Device
510(K) Number	K211553
Device Name	Tecomet Global Unite Short Stem Instrumentation
Applicant	Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. 3724 North State Road 15 Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Mike Parrish 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	05/19/2021
Decision Date	08/04/2021
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