FDA 510(k) Application Details - K201676

Device Classification Name	More FDA Info for this Device
510(K) Number	K201676
Device Name	Barricaid Instrument Tray
Applicant	Intrinsic Therapeutics, Inc. 30 Commerce Way Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Regina Shih Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2020
Decision Date	07/16/2020
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