BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSTEONICS

    Reg #: 2936485 · FEI: 2936485 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER ENDOSCOPY
    Registration Number
    2936485
    FEI Number
    2936485
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5900 Optical Ct
    City
    SAN JOSE
    State
    CA
    ZIP
    95138
    Country
    US

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Bit, Drill HTW

    Proprietary Names

    OSTEONICS NanoTack Flex CinchLock TwinLoop FLEX ACL Workstation Universal ACL Instrumentation NanoTack MicroFX™ Cross-Screw System ICONIX All Suture Anchor System Mainstay Zip Anchor System Meniscal Transplant Set Inter-Lock System BioZip System Xcel Anchor System TwinLoop Anchor System Phoenix VARIOUS TWIST DRILLS DRILL BIT Tornier Drill bits (all) MANUAL DRILL BIT General Instruments 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill 3.9mm Omega Drill 4.75mm AlphaVent and Omega Drill Variable Angle Fixation VariAx, Tap For Bone Screws Knotilus+ 2.4X11.3mm Drill, Hard Bone Knotilus+ 2.9x12.5mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill, Hard Bone Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip Knotilus+ 2.9x12.5mm Drill Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip Knotilus+ 2.9x12.5mm Drill, Hip Knotilus+ 2.9x15.5mm Drill Knotilus+ 2.4x8.9mm Drill, Hip Knotilus+ 2.4x11.3mm Drill

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device