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SeaSpine Orthopedics Corporation

67 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (K253420)SeaSpine Orthopedics Corporation2026-07-01
Virata Spinal Fixation System (K250908)SeaSpine Orthopedics Corporation2025-06-18
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (K243659)SeaSpine Orthopedics Corporation2025-04-02
Cove Putty, OsteoCove Putty (K242273)SeaSpine Orthopedics Corporation2024-09-25
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 (K241466)SeaSpine Orthopedics Corporation2024-06-20
Reef L Interbody System; WaveForm L Interbody System (K240566)SeaSpine Orthopedics Corporation2024-04-26
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 (K232566)SeaSpine Orthopedics Corporation2024-04-19
Meridian Interbody System; WaveForm A Interbody System (K233694)SeaSpine Orthopedics Corporation2024-01-12
Shoreline ACS Interbody System; Shoreline RT Interbody System (K233414)SeaSpine Orthopedics Corporation2023-11-28
Cove Strip, OsteoCove Strip (K232668)SeaSpine Orthopedics Corporation2023-09-27
Cove Putty, OsteoCove Putty (K231030)SeaSpine Orthopedics Corporation2023-09-14
Cove Strip (K230486)SeaSpine Orthopedics Corporation2023-08-21
Manta Ray TDF Spacer (K220296)SeaSpine Orthopedics Corporation2023-02-03
SeaSpine 7D Navigation Instruments (K222753)SeaSpine Orthopedics Corporation2022-12-09
WaveForm A Interbody System (K222732)SeaSpine Orthopedics Corporation2022-11-07
Mariner RDX System (K222110)SeaSpine Orthopedics Corporation2022-09-07
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (K220711)SeaSpine Orthopedics Corporation2022-05-10
WaveForm L System, WaveForm TO System, WaveForm TA System (K213420)SeaSpine Orthopedics Corporation2022-05-04
SeaSpine WaveForm C Interbody System (K212904)SeaSpine Orthopedics Corporation2021-12-14
SeaSpine WaveForm, C Interbody System (K213359)SeaSpine Orthopedics Corporation2021-12-09
Mariner Pedicle Screw System (K212692)SeaSpine Orthopedics Corporation2021-09-21
Explorer TO System (K212540)SeaSpine Orthopedics Corporation2021-09-10
Admiral ACP System (K212139)SeaSpine Orthopedics Corporation2021-09-01
Shoreline Threaded TruProfile® Plate (K211903)SeaSpine Orthopedics Corporation2021-08-30
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 (K210497)SeaSpine Orthopedics Corporation2021-07-07
Mariner Deformity System (K211606)SeaSpine Orthopedics Corporation2021-06-23
SeaSpine WaveForm™ A Interbody System (K210583)SeaSpine Orthopedics Corporation2021-06-02
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System (K201755)SeaSpine Orthopedics Corporation2020-12-15
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 (K201193)SeaSpine Orthopedics Corporation2020-11-25
Seaspine WaveForm C Interbody System (K201073)SeaSpine Orthopedics Corporation2020-09-18
Shoreline ACS (Anterior Cervical System) (K201646)SeaSpine Orthopedics Corporation2020-09-14
Admiral ACP System (K202064)SeaSpine Orthopedics Corporation2020-08-26
Mariner Cap System (K201240)SeaSpine Orthopedics Corporation2020-08-05
SeaSpine Meridian System, SeaSpine Regatta Lateral System (K200879)SeaSpine Orthopedics Corporation2020-06-10
Meridian Anterior Plate System, Regatta Lateral Plate System (K200885)SeaSpine Orthopedics Corporation2020-05-28
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (K200290)SeaSpine Orthopedics Corporation2020-05-11
SeaSpine Reef TH System (K193636)SeaSpine Orthopedics Corporation2020-04-24
NorthStar™ OCT Spinal System (K193615)SeaSpine Orthopedics Corporation2020-03-25
SeaSpine Skipjack System (K193418)SeaSpine Orthopedics Corporation2020-03-13
Daytona® Small Stature Spinal System (K200381)SeaSpine Orthopedics Corporation2020-02-28
Daytona® Small Stature Growth Rod Conversion Set (K193224)SeaSpine Orthopedics Corporation2020-02-13
SeaSpine Beachside System (K192132)SeaSpine Orthopedics Corporation2019-12-03
Resorbable Mesh Device (K193040)SeaSpine Orthopedics Corporation2019-11-30
Mariner MIS Pedicle Screw System; SeaSpine Navigation System (K191648)SeaSpine Orthopedics Corporation2019-07-19
Mariner Outrigger Revision System (K183639)SeaSpine Orthopedics Corporation2019-05-23
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (K190655)SeaSpine Orthopedics Corporation2019-04-29
Shoreline Cervical Interbody RT System (K183083)SeaSpine Orthopedics Corporation2019-02-14
SeaSpine Regatta Lateral System (K181079)SeaSpine Orthopedics Corporation2018-07-18
SeaSpine Daytona Small Stature Spinal System (K180686)SeaSpine Orthopedics Corporation2018-05-14
SeaSpine Navigation System (K172517)SeaSpine Orthopedics Corporation2018-05-11
SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device (K173606)SeaSpine Orthopedics Corporation2018-04-13
SeaSpine Spinous Process System (K173334)SeaSpine Orthopedics Corporation2018-02-22
SeaSpine NewPort Spinal System (K180176)SeaSpine Orthopedics Corporation2018-02-20
SeaSpine Mariner Pedicle Screw System (K173882)SeaSpine Orthopedics Corporation2018-02-06
SeaSpine Cabo ACP (Anterior Cervical Plate) System (K173521)SeaSpine Orthopedics Corporation2018-01-24
SeaSpine Vu cPOD, Zuma-C, Complete Cervical (K172926)SeaSpine Orthopedics Corporation2017-12-21
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (K173260)SeaSpine Orthopedics Corporation2017-12-04
Resorbable Mesh Device (K172130)SeaSpine Orthopedics Corporation2017-11-16
SeaSpine Ventura NanoMetalene System (K173022)SeaSpine Orthopedics Corporation2017-10-26
SeaSpine Cambria System (K171046)SeaSpine Orthopedics Corporation2017-07-07
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K170569)SeaSpine Orthopedics Corporation2017-06-15
SeaSpine® Daytona® Small Stature Spinal System (K163604)SeaSpine Orthopedics Corporation2017-03-09
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (K162351)SeaSpine Orthopedics Corporation2016-12-01
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene (K162715)SeaSpine Orthopedics Corporation2016-10-28
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K161081)SeaSpine Orthopedics Corporation2016-09-14
SeaSpine® NewPort™ Spinal System (K161535)SeaSpine Orthopedics Corporation2016-09-08
Mariner Pedicle Screw System (K160902)SeaSpine Orthopedics Corporation2016-05-26

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Every clearance here is in the API, with alerts when new ones post.