FDA 510(k) Application Details - K092162

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K092162
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST., SUITE 510 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	SAEYOUNG AHN 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	07/16/2009
Decision Date	01/06/2010
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