FDA 510(k) Application Details - K171630

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K171630
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Precifit Medical Ltd 951 Aviation Pkwy Ste 100 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	ZhenYu (Eric) Wu Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2017
Decision Date	07/25/2017
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