FDA 510(k) Application Details - K181348

Device Classification Name	More FDA Info for this Device
510(K) Number	K181348
Device Name	Cartiva SCI Disposable Instrumentation Set
Applicant	Cartiva, Inc. 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Tanya Eberle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2018
Decision Date	06/20/2018
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