BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Arthrex Singapore Pte Ltd.

    Reg #: 3014004349 · FEI: 3014004349 · Expires 2026
    View on FDA
    Products
    71
    Proprietary Names
    120
    Establishment Types
    1
    Classifications
    71

    Registration Details

    Registration Name
    Arthrex Singapore Pte Ltd.
    Registration Number
    3014004349
    FEI Number
    3014004349
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21 Biopolis Road, Nucleos North Tower Unit 03-08
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K221099

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Camera, Television, Surgical, Without Audio FWB
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Staple, Fixation, Bone JDR
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Bone Wedge PLF
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Finger Cot LZB
    Suture, Nonabsorbable, Silk GAP
    Light, Surgical, Fiberoptic FST
    Accessories, Arthroscopic NBH
    Instrument, Manual, Surgical, General Use MDM
    Cerclage, Fixation JDQ
    Tray, Surgical, Instrument FSM
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Rod, Fixation, Intramedullary And Accessories HSB
    Pin, Fixation, Smooth HTY
    Forceps, Rongeur, Surgical EMH
    Shoulder Prosthesis, Reverse Configuration PHX
    Staple Driver HXJ
    Bit, Drill HTW
    Balance, Analytical JQO
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Probe HXB
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Retention Device, Suture KGS
    Operating Room Accessories Table Tray FWZ
    Gauge, Depth HTJ
    System, X-Ray, Angiographic IZI
    Syringe, Piston FMF
    Instrument, Biopsy KNW
    Chisel, Surgical, Manual FZO
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Medical Device Data System OUG
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Filler, Bone Void, Calcium Compound MQV
    Bur, Surgical, General & Plastic Surgery GFF
    Dilator, Lachrymal HNW
    Clamp HXD
    Reamer HTO
    Staple, Absorbable MNU
    Guide, Drill, Ligament LXI
    Mallet HXL
    Forceps HTD
    Controller, Foot, Handpiece And Cord EBW
    Punch, Surgical LRY
    Camera, Cine, Endoscopic, Without Audio FWL
    Dressing, Wound, Drug FRO
    Protector, Skin Pressure FMP
    Template HWT
    Shoulder Arthroplasty Implantation System QHE
    System, Image Processing, Radiological LLZ
    Camera, Surgical And Accessories KQM
    Component, Traction, Non-Invasive KQZ
    Loop, Wire JYQ
    Instrument, Cutting, Orthopedic HTZ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Table And Attachments, Operating-Room BWN
    Orthopedic Manual Surgical Instrument LXH
    Needle, Suturing, Disposable GAB
    Apparatus, Traction, Non-Powered HST
    Expander, Surgical, Skin Graft FZW

    Proprietary Names

    Camera, Television, Surgical, Without Audio FiberTape Fiberstick FiberWire ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P CORKSCREW ANCHORS Arthrex Suture Laproscopes smooth or threaded metallic bone fixation fastener Metallic Bone Fixation Biosync Bone wedge Biosync FINGERSHIELD BIO-ABSORBABLE CORKSCREW VARIOUS INSTRUMENTS Arthrex Distal Extremity Plate System Instrument, manual, surgical, general use orthopedic manual instrument Sutter CURIS RF Generator Forceps, Rongeur, Surgical INTERFERENCE SCREWS Arthroscope DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER drill bit Balance, Analytical iBalance Arthrex PCL TightRope SHAVER SYSTEM BIO-BUTTON ARTHROSCOPY LEG HOLDER Arthrex Graft-Anchor DOUBLE SYRINGE (ACP) SYSTEM fixation pin fixation plate DISCOSCOPES, CERVICAL ENDOSCOPES Graft Delivery Device with Integrated Stylet Chisel, Surgical, Manual Arthrex Fracture Plates Arthrex Univers Apex Shoulder joint metal/ polymer semi-constrained cemented prosthesis LOW PROFILE PLATE AND SCREW SYSTEM PUSHLOCK Arthroscopes Arthrex Low Profile Screws COMPRESSION STAPLE Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener CONTINUOUS WAVE III Arthrex Tibial GraftBolt Syringe, piston SHAVER BLADES Arthrex Plates, Screws, and Staples BI-CORTICAL BIO-POST AND WASHER HATRIC VARIOUS BURS elevator, surgical, general & plastic surgery Clamp Dual Wave Pump Univers Revers Shoulder Prosthesis System OSTEOTOMY PLATE UNIVERS II Fracture Plates & Screws BIO-POST AND WASHER Arthrex Pushlock BIO-COMPRESSION SCREW BIO-CORKSCREW FT TENODESIS FAMILY Mallet BIOCOMPOSITE SUTURE ANCHORS Arthrex PushLock ARTHROSCOPY PUMP AR-200 - Clips MENISCAL DART, DARTSTICK, CHONDRAL DART CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Procellera Composite Antibacterial Wound Dressing Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Arthrex Biocomposite Transfix Orthopedic Template WASHER Arthrex BioComposite SutureTak BIOCOMPOSITE INTERFERENCE SCREW Arthrex MicroSuture Anchors Bio-Composite SutureTak Mini TightRope CMC Camera Heads INTERFERENCE SCREW Component, Traction, Non-Invasive TAK FAMILY Fastener, Fixation, nondegradable, soft tissue Loop, wire TRIM-IT FAMILY HUMERAL FRACTURE PLATE Arthrex Tibial GraftBolt FASTAK SUTURE ANCHOR Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System RETROBUTTON Arthrex Fracture System MINI TIGHTROPE Table Attachments, Operating-Room ORTHOPEDIC MANUAL INSTRUMENTS Arthrex Fracture Plates and Screws OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Arthrex SwiveLock Anchors ACL TightRope Double Bundle ARTHROERESIS IMPLANT FIBERWIRE BUTTON REPAIR KIT PARS Needle SHOULDER HOLDER Apparatus, Traction, Non-Powered BIO-PIN UNIVERS SHOULDER

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device