FDA 510(k) Applications Submitted by Gina Flores

FDA 510(k) Number Submission Date Device Name Applicant
K180176 01/22/2018 SeaSpine NewPort Spinal System SeaSpine Orthopedics Corporation
K170569 02/27/2017 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SeaSpine Orthopedics Corporation
K180686 03/15/2018 SeaSpine Daytona Small Stature Spinal System SeaSpine Orthopedics Corporation
K160902 04/01/2016 Mariner Pedicle Screw System SEASPINE ORTHOPEDICS CORPORATION
K171046 04/07/2017 SeaSpine Cambria System SeaSpine Orthopedics Corporation
K181079 04/24/2018 SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation
K172517 08/21/2017 SeaSpine Navigation System SeaSpine Orthopedics Corporation
K162351 08/23/2016 SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device SEASPINE ORTHOPEDICS CORPORATION
K172926 09/25/2017 SeaSpine Vu cPOD, Zuma-C, Complete Cervical SeaSpine Orthopedics Corporation
K173022 09/28/2017 SeaSpine Ventura NanoMetalene System SeaSpine Orthopedics Corporation
K162715 09/29/2016 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene SeaSpine Orthopedics Corporation
K173260 10/10/2017 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e╖POD System SeaSpine Orthopedics Corporation
K173334 10/23/2017 SeaSpine Spinous Process System SeaSpine Orthopedics Corporation
K183083 11/06/2018 Shoreline Cervical Interbody RT System SeaSpine Orthopedics Corporation
K173521 11/14/2017 SeaSpine Cabo ACP (Anterior Cervical Plate) System SeaSpine Orthopedics Corporation
K173606 11/21/2017 SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device SeaSpine Orthopedics Corporation
K143551 12/15/2014 Compex Wireless USA DJO, LLC
K163604 12/21/2016 SeaSpine« Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation
K173882 12/21/2017 SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation
K183639 12/26/2018 Mariner Outrigger Revision System SeaSpine Orthopedics Corporation


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