FDA 510(k) Application Details - K120538

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K120538
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	KOREA BONE BANK CO., LTD 325 N PUENTE ST UNIT B BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	APRIL 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	02/22/2012
Decision Date	03/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review