BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZSFAB INC

    Reg #: 3022943642 · FEI: 3022943642 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ZSFAB INC
    Registration Number
    3022943642
    FEI Number
    3022943642
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    96 Clematis Ave, STE 2F
    City
    Waltham
    State
    MA
    ZIP
    02453
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252610

    Owner / Operator

    Firm Name
    ZSFab Inc
    Operator Number
    10084929
    Address
    96 Clematis Ave, STE 2F
    City
    Waltham
    State
    MA
    Postal Code
    02453
    Country
    US
    Correspondent
    Xuewei Ma

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Orthopedic Manual Instrument ZSFab Lumbar Interbody System ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System ZSFab Cervical Interbody System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility