BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Artelon

    Reg #: 3033273526 · FEI: 3033273526 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Artelon
    Registration Number
    3033273526
    FEI Number
    3033273526
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    380 Michel St. N.W, Suite A
    City
    ATL
    State
    GA
    ZIP
    30313
    Country
    US

    Regulatory Submissions

    510(k) Number
    K260317

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament QWJ
    Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon OWW
    Mesh, Surgical, Polymeric FTL
    Bit, Drill HTW

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device