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SeaSpine Orthopedics Corporation

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66
Categories12
Latest Approval2025-06-18
TypeNumberDevice NameCodeDate
510(k) K250908 Virata Spinal Fixation System NKB 2025-06-18 View
510(k) K243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments OLO 2025-04-02 View
510(k) K242273 Cove Putty, OsteoCove Putty MQV 2024-09-25 View
510(k) K241466 Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System MAX 2024-06-20 View
510(k) K240566 Reef L Interbody System; WaveForm L Interbody System MAX 2024-04-26 View
510(k) K232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System NKB 2024-04-19 View
510(k) K233694 Meridian Interbody System; WaveForm A Interbody System MAX 2024-01-12 View
510(k) K233414 Shoreline ACS Interbody System; Shoreline RT Interbody System OVE 2023-11-28 View
510(k) K232668 Cove Strip, OsteoCove Strip MQV 2023-09-27 View
510(k) K231030 Cove Putty, OsteoCove Putty MQV 2023-09-14 View
510(k) K230486 Cove Strip MQV 2023-08-21 View
510(k) K220296 Manta Ray TDF Spacer ODP 2023-02-03 View
510(k) K222753 SeaSpine 7D Navigation Instruments OLO 2022-12-09 View
510(k) K222732 WaveForm A Interbody System MAX 2022-11-07 View
510(k) K222110 Mariner RDX System NKB 2022-09-07 View
510(k) K220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System MAX 2022-05-10 View
510(k) K213420 WaveForm L System, WaveForm TO System, WaveForm TA System MAX 2022-05-04 View
510(k) K212904 SeaSpine WaveForm C Interbody System OVE 2021-12-14 View
510(k) K213359 SeaSpine WaveForm, C Interbody System OVE 2021-12-09 View
510(k) K212692 Mariner Pedicle Screw System NKB 2021-09-21 View
510(k) K212540 Explorer TO System MAX 2021-09-10 View
510(k) K212139 Admiral ACP System KWQ 2021-09-01 View
510(k) K211903 Shoreline Threaded TruProfile® Plate KWQ 2021-08-30 View
510(k) K210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System MAX 2021-07-07 View
510(k) K211606 Mariner Deformity System NKB 2021-06-23 View
510(k) K210583 SeaSpine WaveForm™ A Interbody System MAX 2021-06-02 View
510(k) K201755 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System MAX 2020-12-15 View
510(k) K201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System MAX 2020-11-25 View
510(k) K201073 Seaspine WaveForm C Interbody System OVE 2020-09-18 View
510(k) K201646 Shoreline ACS (Anterior Cervical System) OVE 2020-09-14 View
510(k) K202064 Admiral ACP System KWQ 2020-08-26 View
510(k) K201240 Mariner Cap System OWI 2020-08-05 View
510(k) K200879 SeaSpine Meridian System, SeaSpine Regatta Lateral System MAX 2020-06-10 View
510(k) K200885 Meridian Anterior Plate System, Regatta Lateral Plate System KWQ 2020-05-28 View
510(k) K200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) MQV 2020-05-11 View
510(k) K193636 SeaSpine Reef TH System MAX 2020-04-24 View
510(k) K193615 NorthStar™ OCT Spinal System NKG 2020-03-25 View
510(k) K193418 SeaSpine Skipjack System MAX 2020-03-13 View
510(k) K200381 Daytona® Small Stature Spinal System NKB 2020-02-28 View
510(k) K193224 Daytona® Small Stature Growth Rod Conversion Set PGM 2020-02-13 View
510(k) K192132 SeaSpine Beachside System MAX 2019-12-03 View
510(k) K193040 Resorbable Mesh Device MQV 2019-11-30 View
510(k) K191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation System NKB 2019-07-19 View
510(k) K183639 Mariner Outrigger Revision System NKB 2019-05-23 View
510(k) K190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System OVE 2019-04-29 View
510(k) K183083 Shoreline Cervical Interbody RT System ODP 2019-02-14 View
510(k) K181079 SeaSpine Regatta Lateral System MAX 2018-07-18 View
510(k) K180686 SeaSpine Daytona Small Stature Spinal System NKB 2018-05-14 View
510(k) K172517 SeaSpine Navigation System OLO 2018-05-11 View
510(k) K173606 SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device OVD 2018-04-13 View
510(k) K173334 SeaSpine Spinous Process System PEK 2018-02-22 View
510(k) K180176 SeaSpine NewPort Spinal System NKB 2018-02-20 View
510(k) K173882 SeaSpine Mariner Pedicle Screw System NKB 2018-02-06 View
510(k) K173521 SeaSpine Cabo ACP (Anterior Cervical Plate) System KWQ 2018-01-24 View
510(k) K172926 SeaSpine Vu cPOD, Zuma-C, Complete Cervical ODP 2017-12-21 View
510(k) K173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System MAX 2017-12-04 View
510(k) K172130 Resorbable Mesh Device MQV 2017-11-16 View
510(k) K173022 SeaSpine Ventura NanoMetalene System MAX 2017-10-26 View
510(k) K171046 SeaSpine Cambria System ODP 2017-07-07 View
510(k) K170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone System OVE 2017-06-15 View
510(k) K163604 SeaSpine® Daytona® Small Stature Spinal System NKB 2017-03-09 View
510(k) K162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device OVD 2016-12-01 View
510(k) K162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene MAX 2016-10-28 View
510(k) K161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone System OVE 2016-09-14 View
510(k) K161535 SeaSpine® NewPort™ Spinal System NKB 2016-09-08 View
510(k) K160902 Mariner Pedicle Screw System NKB 2016-05-26 View
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