BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Stryker Macroom

    Reg #: 3008337808 · FEI: 3008337808 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    124
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    Stryker Macroom
    Registration Number
    3008337808
    FEI Number
    3008337808
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hartnetts Cross, Macroom
    City
    Co Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K994392

    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
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Screw, Fixation, Bone HWC
    Prosthesis, Elbow, Constrained, Cemented JDC
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Plate, Fixation, Bone HRS
    Bit, Drill HTW
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Cement Obturator LZN
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Screwdriver HXX

    Proprietary Names

    Aequalis Shoulder System - glenoid AEQUALIS REVERSED PROSTHESIS Aequalis Ascend Flex Shoulder System Aequalis Reversed Shoulder Prosthesis DART-FIRE EDGE Cannulated Screws Aequalis Shoulder System Tornier Perform Anatomic Glenoid LATITUDE EV ORTHOLOC 3DI Ankle Fusion System ORTHOLOC, ORTHOLOC 3Di ORTHOLOC ORTHOLOC 3Di PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Aequalis Reversed Titanium Glenoid Sphere Aequalis Ascend Flex Titanium Head Aequalis Reversed II - Threaded Post Baseplate Aequalis Shoulder Fracture System 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 Elbow joint radial (hemi-elbow) polymer prosthesis Elbow joint metal/polymer semi-constrained cemented prosthesis Latitude Elbow Prosthesis ORTHOLOC 3Di Foot Reconstruction System ORTHOLOC 3Di Hallux System Aequalis Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed Tornier Perform® Reversed Glenoid Cannulated Glenospheres Cement Restrictor Tornier Flex Shoulder System Aequalis" Ascend" Flex Shoulder System AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 Plus stem Tornier Perform™ Humeral System TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 Plus stem Aequalis Shoulder system ASCEND SHOULDER SYSTEM Aequalis Reversed Fracture Shoulder Prosthesis Aequalis Ascend FLEX Shoulder System Graft Box Compression Screw Graft Box Locking Screw Graft releasing bell central blade Bell Saw Graft Sizer Graft releasing bell external blade Blade Unlocker Graft Box Body Curved Reamer Head Graft Releasing Bell Handle Releasing Bell Central Blade Tornier Perform Reversed MonoPost Glenoid Flat Humeral Reamer Head Graft Extractor Releasing Bell External Blade Releasing Bell Shaft Baseplate post drill Flat Glenoid Reamer Head Graft Box Washer Graft Box Wedge Graft Container Graft releasing bell shaft Flat glenoid Neo reamer head Post Drill Curved glenoid Neo reamer head Graft Releasing Bell Glenoid Pin Guide LATITUDE EV Total Elbow Arthroplasty AEQUALIS PERFORM REVERSED Tornier Perform Anatomic Augmented Glenoid Aequalis PerFORM+ SET SCREWDRIVER STRYKER AUTOMATIC SCREWDRIVER Biosteon Wedge Interference Screw System Bioabsorable Wedge Interference Screw System ACL Reconstruction Accessories ORTHOPEDIC SCREWDRIVER DRIVER; SCREW INSERTER CalcLock Extreme MaxLock Extreme Screwdriver MaxTorque Mini MaxTorque Intraosseous Fixation System HexStar DRLock Extreme Mini MaxLock Mini Variable

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)