BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURGTECH, INC.

    Reg #: 3011170410 · FEI: 3011170410 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    SURGTECH, INC.
    Registration Number
    3011170410
    FEI Number
    3011170410
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    24600 Center Ridge Road, Suite 195
    City
    Westlake
    State
    OH
    ZIP
    44145
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162125

    Owner / Operator

    Firm Name
    SurgTech, Inc.
    Operator Number
    10047514
    Address
    24600 Center Ridge Road, Suite 195
    City
    Westlake
    State
    OH
    Postal Code
    44145
    Country
    US
    Correspondent
    Cheng Bao

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    SurgTech Total Hip SurgTech Trauma Plates and Screws SurgTech Knee System SurgTech Bipolar SurgTech Posterior Fusion SurgTech TLS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device