FDA 510(k) Application Details - K142655

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K142655
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	CHIN BONE TECHNIQUE CORP 1F., NO. 165, SEC, 2, XIAN ST., BEITOU DIST. TAIPEI 11274 TW Other 510(k) Applications for this Company
Contact	CHENG-KUNG CHENG Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2014
Decision Date	01/26/2015
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