FDA 510(k) Application Details - K190408

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K190408
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	Shangdong Kangsheng Medical Devices Co., Ltd. North of Industrial Park, Dawenkou Gypsum Tai'an City 271000 CN Other 510(k) Applications for this Company
Contact	Wenxing Dong 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	02/21/2019
Decision Date	06/16/2020
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