BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Stryker Ireland Ltd. Instruments Division, Innovation Centre

    Reg #: 3040335671 · FEI: 3040335671 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    93
    Establishment Types
    1
    Classifications
    27

    Registration Details

    Registration Name
    Stryker Ireland Ltd. Instruments Division, Innovation Centre
    Registration Number
    3040335671
    FEI Number
    3040335671
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Carrigtwohill Business & Technology Park
    City
    Carrigtwohill Cork (County)
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K213824

    Owner / Operator

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

    US Agent

    Business Name
    STRYKER INSTRUMENTS
    Contact Name
    Kim Wiersema
    Address
    1941 Stryker Way
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US
    Email
    [email protected]
    Phone
    269 2545351

    Products

    Device Name Product Code
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Ultrasonic Surgical LFL
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Catheter, Irrigation GBX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Bit, Surgical GFG
    Pin, Fixation, Smooth HTY
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Bone Cement, Posterior Screw Augmentation PML
    Bone Cement LOD
    Cement, Bone, Vertebroplasty NDN
    Trap, Sterile Specimen BYZ
    Blade, Saw, Surgical, Cardiovascular DWH
    Bur, Surgical, General & Plastic Surgery GFF
    Orthopedic Stereotaxic Instrument OLO
    Brush, Dermabrasion, Powered GFE
    Bur, Ear, Nose And Throat EQJ
    Instrument, Cast Removal, Ac-Powered LGH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Splint, Intranasal Septal LYA
    Bur, Dental EJL
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Drills, Burrs, Trephines & Accessories (Compound, Powered) HBF
    Motor, Drill, Pneumatic HBB
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
    Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision SFQ

    Proprietary Names

    NexFix IMN™ Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF 12cm iQ Apex 360 12cm iQ Standard 10cm iQ Broad Knife 12cm iQ Serrated Large 12cm iQ Barracuda 12cm iQ Large 18cm iQ Apex Micro Claw SONOPET IQ CONSOLE 18cm iQ Micro Claw 12cm iQ Micro 12cm iQ 120 Claw 11cm iQ Knife 12cm iQ Micro Claw 12cm iQ Claw 20cm iQ Apex 360 11cm iQ Apex Knife 20cm iQ Standard IRRIGATION 5MM FLEXIBLE REAMER 6MM FLEXIBLE REAMER 11MM FLEXIBLE REAMER 7.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER 7MM FLEXIBLE REAMER 12MM FLEXIBLE REAMER 11.5MM FLEXIBLE REAMER 8MM FLEXIBLE REAMER 6.5MM FLEXIBLE REAMER 9.5MM FLEXIBLE REAMER FLEXIBLE GUIDE PIN VERSITOMIC STERILE FLEXIBLE PIN 10MM FLEXIBLE REAMER 5.5MM FLEXIBLE REAMER 8.5MM FLEXIBLE REAMER 9MM FLEXIBLE REAMER 10.5MM FLEXIBLE REAMER AEQUALIS REVERSED BIT General Surgical Bits Kirschner Wire 0485-840-000 - XL Round Diamond Bur, 4 mm 0485-860-000 - XL Round Diamond Bur, 5.5 mm Dual Edge Shaver Blade 4mm Dual Edge Shaver Blade 5.5mm Tomcat HC Shaver Blade 4mm Aggressive Max Shaver Blade 3.5mm Smooth Bite Shaver Blade 3.5mm Dual Edge Shaver Blade 3.5mm Bursector 5.5 mm Bursector 4 mm PCD PREC. SYS LONG TUBE W/VertaPlex HV PCD kit Short tube with Vertaplex HV PCD Kit Long tube with VertaPlex HV Autoplex with Vertaplex HV AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV 4 mm ENT MicroDebrider JAGUAR ORTHOVAC CASTVAC 4mm TomCat Shaver Blades 5mm HellCat Shaver Blades ATTACHMENTS PKG., DUAL EDGE SHAVER BLADE - 5.5MM HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE SMOOTH BITE SHAVER BLADE - 3.5MM SAW BLADE HLS KNEETEC PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill Stryker Aria Pneumatic System 7.5MM Round

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility