BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALPHATEC SPINE, INC.

    Reg #: 3015537048 · FEI: 3015537048 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ALPHATEC SPINE, INC.
    Registration Number
    3015537048
    FEI Number
    3015537048
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    168 Centennial Parkway, Unit 170
    City
    Louisville
    State
    CO
    ZIP
    80027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232413

    Owner / Operator

    Firm Name
    ALPHATEC HOLDINGS, INC.
    Operator Number
    9072657
    Address
    1950 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Brian - Beireis

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Orthopedic Manual Surgical Instrument LXH
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    Valence Robotic Navigation System Remi Robotic Navigation System Orthopedic Manual Surgical Instrument Sterilization Container used with Remi Robotic Navigation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device