FDA 510(k) Application Details - K100516

Device Classification Name	More FDA Info for this Device
510(K) Number	K100516
Device Name	ANYPLUS PEEK CAGES
Applicant	GS MEDICAL CO., LTD. 111 HILL ROAD PO BOX 395 DOUGLASSVILLE, PA 19818 US Other 510(k) Applications for this Company
Contact	DONALD W GUTHNER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2010
Decision Date	12/03/2010
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