FDA 510(k) Application Details - K223776

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K223776
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Changzhou Geasure Medical Apparatus and Instruments Co., Ltd No. 12, Jinfeng Road West Taihu Science and Technology Industrial Park Changzhou 213149 CN Other 510(k) Applications for this Company
Contact	Jing Huang 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	12/16/2022
Decision Date	03/03/2023
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