FDA 510(k) Application Details - K190067

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K190067
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	U&i Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si 11781 KR Other 510(k) Applications for this Company
Contact	Jee-Ae Bang Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2019
Decision Date	02/04/2019
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