FDA 510(k) Application Details - K173215

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K173215
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 US Other 510(k) Applications for this Company
Contact	Kim Finch Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2017
Decision Date	01/19/2018
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