BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SeaSpine Regatta Lateral System

    Reg #: 3012120772 · FEI: 3012120772 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    SEASPINE ORTHOPEDICS CORPORATION
    Registration Number
    3012120772
    FEI Number
    3012120772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5770 Armada Dr
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210497

    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
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    SeaSpine Regatta Lateral System SeaSpine Cambria System SeaSpine Beachside System Shoreline Cervical Interbody RT System SeaSpine Vu aPod Prime NanoMetalene Vu aPod L NanoMetalene SeaSpine Meridian System SeaSpine Spacer System – Hollywood NanoMetalene, Hollywood VI NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene SeaSpine Vu ePod System SeaSpine Reef TH System SeaSpine Shoreline ACS - Anterior Cervical System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device