FDA 510(k) Application Details - K173074

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K173074
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Stryker 5670 Greenwood Plaza Blvd. Suite 200 Greenwood Village, CO 80111 US Other 510(k) Applications for this Company
Contact	Jacob Scheenstra Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	04/04/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review