BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TESLAKE, INC.

    Reg #: 3016496998 · FEI: 3016496998 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    TESLAKE, INC.
    Registration Number
    3016496998
    FEI Number
    3016496998
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17150 Via Del Campo, Suite 308
    City
    San Diego
    State
    CA
    ZIP
    92127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140348

    Owner / Operator

    Firm Name
    Teslake, Inc.
    Operator Number
    10062341
    Address
    7 Beechbrook Lane
    City
    Rochester
    State
    NY
    Postal Code
    14625
    Country
    US
    Correspondent
    Lukas Eisermann

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthopedic Stereotaxic Instrument OLO
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW

    Proprietary Names

    Interbody Cage Modular Pedicle Screw (MPS) System Cervical Plate MPS System Fixation Pin

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility