FDA 510(k) Application Details - K190446

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K190446
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401 US Other 510(k) Applications for this Company
Contact	Douglas Kohrs 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	02/25/2019
Decision Date	03/27/2019
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