FDA 510(k) Application Details - K103414

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K103414
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	L&K BIOMED CO.,LTD. #1104 ACE HIGH-END TOWER 3 CHA 371-50 GASAN-DONG GEUMCHOEN-GU SEOUL 153-803 KR Other 510(k) Applications for this Company
Contact	SUN YI LEE Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2010
Decision Date	07/22/2011
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