FDA 510(k) Application Details - K173411

Device Classification Name	More FDA Info for this Device
510(K) Number	K173411
Device Name	Comprehensive Segmental Revision System (SRS)
Applicant	Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580 US Other 510(k) Applications for this Company
Contact	Patricia Sandborn Beres 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	11/01/2017
Decision Date	02/08/2018
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