Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012120772

FEI Number

3012120772

Entity Name

SEASPINE ORTHOPEDICS CORPORATION

City/State/Country

Carlsbad, CA, US

Establishment Address

5770 Armada Dr, Carlsbad, CA 92008, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SeaSpine Orthopedics Corporation (Owner Number: 10049589)

Owner / Operator Contact Address

5770 Armada Dr, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vu cPOD IBF Admiral ACP System Coral Spinal System UCR Malibu Sierra Newport Explorer TO System Admiral ACP System Atoll OCT Spinal System Vu aPOD Vu aPOD-L SeaSpine Meridian System SeaSpine Regatta Lateral System Shoreline Cervical Interbody RT System SeaSpine Regatta Lateral System Shoreline ACS (Anterior Cervical System) SeaSpine Meridian System SeaSpine Cambria System SeaSpine Reef TH System SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device SeaSpine Vu ePOD System SeaSpine Spacer System (Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene) SeaSpine Reef TO/TA System Newport Zuma-L Hollywood Anterior Disc Prep Regatta Lateral System Reef L Interbody System Posterior Disc Prep Newport Malibu Mariner Lattus Fathom Pedicle-Based Retractor Coral Spinal System Malibu Spinal System Zuma Malibu Spinal System Shoreline ACS (Anterior Cervical System) SeaSpine Spacer System Vu aPOD Intervertebral Body Fusion Shoreline Cervical Interbody RT System SeaSpine VBR System Hollywood NanoMetalene SeaSpine Spacer System Cambria NanoMetalene Ventura NanoMetalene SeaSpine WaveForm L, WaveForm TO, WaveForm TA Systems UCR Malibu Mariner Outrigger System Redondo-L SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®; SeaSpine® Cambria NanoMetalene® SeaSpine Coral Spinal System Malibu Spinal System Coral Spinal System Mariner Cap System Vu cPOD UCR Malibu Coral Spinal System Zuma-C Sonoma SeaSpine Cabo ACP (Anterior Cervical Plate) System Malibu Spinal System Regatta System Zuma Newport Facet Fixation Zuma-C Laminoplasty Sonoma Sierra Zuma Pacifica Cambria Zuma-C Hollywood Zuma-L Zuma Redondo Reef L Interbody System Regatta Lateral System Mariner Outrigger Revision System Shoreline ACS Interbody System Posterior Disc Prep Meridian Interbody System Anterior Disc Prep Regatta Lateral Plate System Meridian Anterior Plate System SeaSpine Spinous Process System Sierra Sonoma UCR Malibu Zuma-L Hollywood Ventura Zuma Pacifica Cambria Redondo Zuma-C Sierra Malibu UCR Newport UCR Spinal System Sierra Malibu Newport SeaSpine Laminoplasty System SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device WaveForm A System Vu Mesh Manta Ray TDF Spacer Mariner Pedicle Screw System NewPort Spinal System Mariner MIS Pedicle Screw System Mariner Outrigger Revision System Mariner RDX System Malibu Spinal System Daytona Small Stature Spinal System Mariner Deformity System SeaSpine WaveForm C Interbody System Daytona Small Stature Growth Rod Conversion Set SeaSpine Daytona Small Stature Spinal System VuLPOD Vu ePOD Zuma Hollywood Pacifica Zuma-L Explorer TO System Reef L Interbody System Regatta Lateral System Meridian Interbody System Skipjack Cambria Zuma-L Redondo Hollywood Zuma-C Pacifica Ventura SeaSpine RAPID Graft Delivery Anterior Disc Prep System IsoTis Cervical Facet Prep Instruments Lattus NorthStar Facet Prep Instruments Reef TO/TA System Explorer TO System Shoreline ACS Interbody System Posterior Disc Prep System Mariner RDX System Mariner Pedicle Screw System Daytona Small Stature Spinal System Mariner Deformity System Meridian Interbody System NorthStar OCT System Manta Ray TDF Spacer Regatta Lateral System Admiral ACP System Reef L Interbody System Fathom Pedicle-Based Retractor Mariner MIS Pedicle Screw System Malibu Spinal System NewPort Spinal System SeaSpine Spacer System NM Reef TA System Reef TO System Sierra Zuma-C Sonoma Malibu Newport Zuma Facet Fixation Zuma-L Stainless Steel Spinal System Newport Spinal System Newport Zuma-L Balboa Malibu Zuma-C Sierra Sonoma Zuma Stainless Steel Spinal System Sonoma Laminoplasty Zuma-C Newport Sierra Zuma Sierra Mariner RDX MIS System Mariner RDX System SeaSpine Expandable Intervertebral Body Fusion Device System WaveForm L Interbody System Reef L Interbody System Atoll OCT Spinal System Mariner Deformity System Spinous Process System Cambria Zuma Cordant Zuma-C Zuma Newport Sierra Balboa Sonoma Zuma-L Malibu Sierra Zuma-L Mariner Pedicle Screw System Shoreline ACS (Anterior Cervical System) Balboa Anterior Lumbar Buttress System Daytona Small Stature Spinal System UCR Spinal System WaveForm TO Interbody System WaveForm C Interbody System WaveForm TA Interbody System Shoreline RT Interbody System WaveForm A Interbody System Meridian Interbody System Reef TO/TA System WaveForm L Interbody System Regatta Lateral System Shoreline ACS Interbody System Reef L Interbody System UCR Spinal System UCR Spinal System SeaSpine WaveForm L Interbody System SeaSpine WaveForm TA Interbody System SeaSpine WaveForm TO Interbody System Navigation Instruments Shoreline ACS (Anterior Cervical System) Stainless Steel Spinal System Shoreline TruProfile Threaded Plate Explorer TO System Mariner Pedicle Screw System Mariner Extension Mariner Cortical System and Retractor Set Mariner Pedicle Screw System Vu cPOD IBF Tether Ventura Pacifica UCR Zuma-L Malibu Sierra Shoreline RT Interbody System Shoreline ACS Interbody System Hollywood Newport Zuma-L Newport UCR Malibu Balboa Laminoplasty Sierra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-09-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-09-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-09-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-06-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-06-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2020-11-25
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2020-11-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-11-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-11-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-11-25
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2015-06-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-09-17
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2020-09-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-07-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-07-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-06-28
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-12-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-12-31
HXC	Wrench	Orthopedic	Class 1	888.4540	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-07-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-10-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-10-28
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2020-08-06
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
HXE	Fork	Orthopedic	Class 1	888.4540	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-02-12
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-07-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-06-28
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-06-28
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-06-18
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2018-02-22
HXW	Bender	Orthopedic	Class 1	888.4540	2015-06-28
HTX	Rongeur	Orthopedic	Class 1	888.4540	2015-06-28
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
HXB	Probe	Orthopedic	Class 1	888.4540	2015-06-28
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2016-07-05
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-05-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-06-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-06-24
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-02-21
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2024-08-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-08-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-08-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-08-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-08-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-08-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2020-09-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-09-18
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2020-04-15
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2018-06-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-06-01
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-09-27
HXG	Tamp	Orthopedic	Class 1	888.4540	2015-06-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-06-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-27
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-09-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-09-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-06-28
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-05-09
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-05-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-05-09
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-06-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-06-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-06-25
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2015-10-12
HWA	Impactor	Orthopedic	Class 1	888.4540	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-10-08
HWJ	Awl	Orthopedic	Class 1	888.4540	2015-06-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-07-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-07-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-07-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-07-06
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-06-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-07-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-07-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-07-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-06-21
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-06-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-06-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-06-21
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-06-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-05-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-05-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-06-22
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2016-09-15
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-09-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-06-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-02-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-09-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-09-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-09-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-06-28
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-06-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-12-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-12-14
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-06-28
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2015-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SeaSpine Orthopedics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2090010	ISOTIS ORTHOBIOLOGICS, INC	IRVINE, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012120772. Last updated year: 2026. Please use registration number 3012120772 when referencing this establishment in official correspondence.