FDA 510(k) Application Details - K170861

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K170861
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	Shandong Weigao Orthopaedic Device Co., Ltd. No. 26 Xiangjiang Road, Tourist Resorts Weihai 264203 CN Other 510(k) Applications for this Company
Contact	Han Wang Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2017
Decision Date	08/04/2017
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