Medical Device Manufacturer · US , Carlsbad , CA

SeaSpine Orthopedics Corporation

66 submissions · 66 cleared · Since 2016
66
Total
66
Cleared
0
Denied

SeaSpine Orthopedics Corporation — FDA 510(k) Submissions

SeaSpine Orthopedics Corporation has submitted 66 FDA 510(k) premarket notifications since 2016, of which 66 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Integrated Fixation, Cervical, Filler, Bone Void, Calcium Compound, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

66 devices
1–25 of 66
Virata Spinal Fixation System
K250908 · NKB Thoracolumbosacral... · Orthopedic
Jun 2025 84d
FLASH? Facet Fusion Instruments, IsoTis? Facet Fusion Instruments
K243659 · OLO Orthopedic Stereotaxic... · Orthopedic
Apr 2025 126d
Cove Putty, OsteoCove Putty
K242273 · MQV Filler, Bone Void,... · Orthopedic
Sep 2024 55d
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 · MAX Intervertebral Fusion... · Orthopedic
Jun 2024 28d
Reef L Interbody System; WaveForm L Interbody System
K240566 · MAX Intervertebral Fusion... · Orthopedic
Apr 2024 57d
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 · NKB Thoracolumbosacral... · Orthopedic
Apr 2024 239d
Meridian Interbody System; WaveForm A Interbody System
K233694 · MAX Intervertebral Fusion... · Orthopedic
Jan 2024 56d
Shoreline ACS Interbody System; Shoreline RT Interbody System
K233414 · OVE Intervertebral Fusion... · Orthopedic
Nov 2023 49d
Cove Strip, OsteoCove Strip
K232668 · MQV Filler, Bone Void,... · Orthopedic
Sep 2023 26d
Cove Putty, OsteoCove Putty
K231030 · MQV Filler, Bone Void,... · Orthopedic
Sep 2023 156d
Cove Strip
K230486 · MQV Filler, Bone Void,... · Orthopedic
Aug 2023 179d
Manta Ray TDF Spacer
K220296 · ODP Intervertebral Fusion... · Orthopedic
Feb 2023 366d
SeaSpine 7D Navigation Instruments
K222753 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2022 88d
WaveForm A Interbody System
K222732 · MAX Intervertebral Fusion... · Orthopedic
Nov 2022 59d
Mariner RDX System
K222110 · NKB Thoracolumbosacral... · Orthopedic
Sep 2022 51d
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K220711 · MAX Intervertebral Fusion... · Orthopedic
May 2022 60d
WaveForm L System, WaveForm TO System, WaveForm TA System
K213420 · MAX Intervertebral Fusion... · Orthopedic
May 2022 196d
SeaSpine WaveForm C Interbody System
K212904 · OVE Intervertebral Fusion... · Orthopedic
Dec 2021 92d
SeaSpine WaveForm, C Interbody System
K213359 · OVE Intervertebral Fusion... · Orthopedic
Dec 2021 58d
Mariner Pedicle Screw System
K212692 · NKB Thoracolumbosacral... · Orthopedic
Sep 2021 27d
Explorer TO System
K212540 · MAX Intervertebral Fusion... · Orthopedic
Sep 2021 29d
Admiral ACP System
K212139 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2021 55d
Shoreline Threaded TruProfile? Plate
K211903 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2021 70d
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 · MAX Intervertebral Fusion... · Orthopedic
Jul 2021 135d
Mariner Deformity System
K211606 · NKB Thoracolumbosacral... · Orthopedic
Jun 2021 29d
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