FDA Registration
Active
🇺🇸 United States
SEASPINE ORTHOPEDICS CORPORATION
Reg #: 3012120772
·
FEI: 3012120772
·
Expires 2026
Products
51
Proprietary Names
139
Establishment Types
3
Classifications
51
Registration Details
- Registration Name
- SEASPINE ORTHOPEDICS CORPORATION
- Registration Number
- 3012120772
- FEI Number
- 3012120772
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111675
Owner / Operator
- Firm Name
- SeaSpine Orthopedics Corporation
- Operator Number
- 10049589
- Address
- 5770 Armada Dr
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-06-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-09-18 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2015-06-28 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-09-15 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-06-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-06-28 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2015-06-28 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-11-25 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-06-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-06-28 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2020-12-31 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2015-06-28 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2020-08-06 |
| Fork | HXE | Class 1 | Orthopedic | No | 2015-06-28 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2015-06-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-06-28 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2018-02-22 |
| Bender | HXW | Class 1 | Orthopedic | No | 2015-06-28 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2015-06-28 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2015-06-28 |
| Probe | HXB | Class 1 | Orthopedic | No | 2015-06-28 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2016-07-05 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2024-08-28 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-06-01 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2015-06-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-06-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2015-06-28 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2015-06-28 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2015-06-28 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2015-06-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2015-06-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2018-06-22 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2015-06-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2020-04-24 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2015-06-28 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2015-06-28 |
| Template | HWT | Class 1 | Orthopedic | No | 2015-06-28 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2015-06-28 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2015-06-28 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2015-10-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-06-28 |
Proprietary Names
Vu cPOD IBF
Admiral ACP System
Coral Spinal System
UCR
Malibu
Sierra
Newport
Explorer TO System
Atoll OCT Spinal System
Vu aPOD
Vu aPOD-L
SeaSpine Meridian System
SeaSpine Regatta Lateral System
Shoreline Cervical Interbody RT System
Shoreline ACS (Anterior Cervical 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
Zuma-L
Hollywood
Anterior Disc Prep
Regatta Lateral System
Reef L Interbody System
Posterior Disc Prep
Mariner
Lattus
Fathom Pedicle-Based Retractor
Malibu Spinal System
Zuma
SeaSpine Spacer System
Vu aPOD Intervertebral Body Fusion
SeaSpine VBR System
Hollywood NanoMetalene
Cambria NanoMetalene
Ventura NanoMetalene
SeaSpine WaveForm L, WaveForm TO, WaveForm TA Systems
Mariner Outrigger System
Redondo-L
SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®; SeaSpine® Cambria NanoMetalene®
SeaSpine
Mariner Cap System
Vu cPOD
Zuma-C
Sonoma
SeaSpine Cabo ACP (Anterior Cervical Plate) System
Regatta System
Facet Fixation
Laminoplasty
Pacifica
Cambria
Redondo
Mariner Outrigger Revision System
Shoreline ACS Interbody System
Meridian Interbody System
Regatta Lateral Plate System
Meridian Anterior Plate System
SeaSpine Spinous Process System
Ventura
UCR Spinal System
SeaSpine Laminoplasty System
SeaSpine Vu aPOD Prime 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 RDX 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
Skipjack
RAPID Graft Delivery
Anterior Disc Prep System
IsoTis Cervical Facet Prep Instruments
NorthStar Facet Prep Instruments
Reef TO/TA System
Posterior Disc Prep System
NorthStar OCT System
SeaSpine Spacer System NM
Reef TA System
Reef TO System
Stainless Steel Spinal System
Newport Spinal System
Balboa
Mariner RDX MIS System
SeaSpine Expandable Intervertebral Body Fusion Device System
WaveForm L Interbody System
Spinous Process System
Cordant
Balboa Anterior Lumbar Buttress System
WaveForm TO Interbody System
WaveForm C Interbody System
WaveForm TA Interbody System
Shoreline RT Interbody System
WaveForm A Interbody System
SeaSpine WaveForm L Interbody System
SeaSpine WaveForm TA Interbody System
SeaSpine WaveForm TO Interbody System
Navigation Instruments
Shoreline TruProfile Threaded Plate
Mariner Extension
Mariner Cortical System and Retractor Set
Tether
Bodyform Thoracic Fixation System
SeaSpine Ventura NanoMetalene System
BodyForm System
Virata Spinal Fixation System
SeaSpine Navigation System
Mariner MIS Wayfinder System
Malibu Spinal System with Daytona Deformity System
SeaSpine® Daytona® Small Stature Spinal System
NorthStar OCT Spinal System
Sonoma Anterior Cervical Plate System
Shoreline ACS and RT Interbody System
FORZA XP Expandable Spacer System
Manta Ray Anterior Cervical Plate System
Vu aPOD Prime NanoMetalene
Reef TH System
SeaSpine Spacer System Hollywood NanoMetalene, Hollywood VI NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene
Vu aPod L NanoMetalene
SeaSpine Shoreline ACS - Anterior Cervical System
SeaSpine Beachside System
SeaSpine Vu ePod System
SeaSpine Vu aPod Prime NanoMetalene
SeaSpine Complete Cervical Intervertebral Body Fusion Device
Waveform C Interbody System
Reef TH Interbody System
SeaSpine NewPort Spinal System
Paramount IBF
Facet Fixation System
Meridian System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility