FDA 510(k) Applications Submitted by SEASPINE ORTHOPEDICS CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K200381 02/18/2020 Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation
K190655 03/14/2019 SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System SeaSpine Orthopedics Corporation
K201193 05/04/2020 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aòPOD-L NanoMetalene; SeaSpine Vu eòPOD System; and SeaSpine Reef TH System, SeaSpine Vu aòPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System SeaSpine Orthopedics Corporation
K201240 05/08/2020 Mariner Cap System SeaSpine Orthopedics Corporation
K201646 06/17/2020 Shoreline ACS (Anterior Cervical System) SeaSpine Orthopedics Corporation
K191648 06/20/2019 Mariner MIS Pedicle Screw System; SeaSpine Navigation System SeaSpine Orthopedics Corporation
K193615 12/26/2019 NorthStarÖ OCT Spinal System SeaSpine Orthopedics Corporation
K210497 02/22/2021 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aòPOD-L NanoMetalene, SeaSpine Vu eòPOD System, SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervic SeaSpine Orthopedics Corporation
K210583 02/26/2021 SeaSpine WaveFormÖ A Interbody System SeaSpine Orthopedics Corporation
K200885 04/02/2020 Meridian Anterior Plate System, Regatta Lateral Plate System SeaSpine Orthopedics Corporation
K200879 04/02/2020 SeaSpine Meridian System, SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation
K201073 04/22/2020 Seaspine WaveForm C Interbody System SeaSpine Orthopedics Corporation
K201755 06/29/2020 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System SeaSpine Orthopedics Corporation
K202064 07/27/2020 Admiral ACP System SeaSpine Orthopedics Corporation
K192132 08/07/2019 SeaSpine Beachside System SeaSpine Orthopedics Corporation
K212540 08/12/2021 Explorer TO System SeaSpine Orthopedics Corporation
K213420 10/20/2021 WaveForm L System, WaveForm TO System, WaveForm TA System SeaSpine Orthopedics Corporation
K193418 12/09/2019 SeaSpine Skipjack System SeaSpine Orthopedics Corporation
K193636 12/27/2019 SeaSpine Reef TH System SeaSpine Orthopedics Corporation
K200290 02/05/2020 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) SeaSpine Orthopedics Corporation
K193040 10/31/2019 Resorbable Mesh Device SeaSpine Orthopedics Corporation
K212139 07/08/2021 Admiral ACP System SeaSpine Orthopedics Corporation
K230486 02/23/2023 Cove Strip SeaSpine Orthopedics Corporation
K231030 04/11/2023 Cove Putty, OsteoCove Putty SeaSpine Orthopedics Corporation
K232668 09/01/2023 Cove Strip, OsteoCove Strip SeaSpine Orthopedics Corporation
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
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
K212904 09/13/2021 SeaSpine WaveForm C Interbody System SeaSpine Orthopedics Corporation
K213359 10/12/2021 SeaSpine WaveForm, C Interbody System SeaSpine Orthopedics Corporation
K172130 07/14/2017 Resorbable Mesh Device SeaSpine Orthopedics Corporation
K211606 05/25/2021 Mariner Deformity System SeaSpine Orthopedics Corporation
K222110 07/18/2022 Mariner RDX System SeaSpine Orthopedics Corporation
K212692 08/25/2021 Mariner Pedicle Screw System SeaSpine Orthopedics Corporation
K222732 09/09/2022 WaveForm A Interbody System SeaSpine Orthopedics Corporation
K193224 11/22/2019 Daytona« Small Stature Growth Rod Conversion Set SeaSpine Orthopedics Corporation
K220296 02/02/2022 Manta Ray TDF Spacer SeaSpine Orthopedics Corporation
K220711 03/11/2022 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System SeaSpine Orthopedics Corporation
K211903 06/21/2021 Shoreline Threaded TruProfile« Plate SeaSpine Orthopedics Corporation
K222753 09/12/2022 SeaSpine 7D Navigation Instruments SeaSpine Orthopedics Corporation
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


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