FDA 510(k) Application Details - K151592

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K151592
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. A22 &26, Science & Technology Development Zone, Jinnan Rd., Jinfeng Town Zhangjiagang City 215625 CN Other 510(k) Applications for this Company
Contact	Xue Fang Zhou 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	06/12/2015
Decision Date	09/24/2015
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