BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wedge System

    Reg #: 3012966183 · FEI: 3012966183 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Tyber Medical
    Registration Number
    3012966183
    FEI Number
    3012966183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    83 South Commerce Way, Suite 310
    City
    Bethlehem
    State
    PA
    ZIP
    18017
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150394

    Owner / Operator

    Firm Name
    Tyber Medical LLC
    Operator Number
    10046574
    Address
    83 South Commerce Way, Suite 310
    City
    Bethlehem
    State
    PA
    Postal Code
    18017
    Country
    US

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Bone Wedge PLF

    Proprietary Names

    Wedge System

    Establishment Types

    Repack or Relabel Medical Device