FDA 510(k) Application Details - K061599

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K061599
Device Name	Pin, Fixation, Threaded
Applicant	BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN HWASUNG-SI, KYUNGGI-DO KR Other 510(k) Applications for this Company
Contact	BYUNGJUN PARK Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2006
Decision Date	07/26/2006
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