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FDA 510(k) Applications Submitted by MICHELLE WILLIS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K161081
04/18/2016
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
SEASPINE ORTHOPEDICS CORPORATION
K161535
06/03/2016
SeaSpine« NewPortÖ Spinal System
SEASPINE ORTHOPEDICS CORPORATION
K150469
02/23/2015
Integra Laminoplasty System
SEASPINE, INC.
K071942
07/13/2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK
K142488
09/04/2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
SeaSpine, Inc.
K132859
09/12/2013
INTEGRA FACET FIXATION SYSTEM
SEASPINE, INC.
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