FDA 510(k) Application Details - K153735

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K153735
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 US Other 510(k) Applications for this Company
Contact	Sarah Pleaugh 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	12/28/2015
Decision Date	01/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review