BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    Device Innovation Company Limited

    Reg #: 3012818475 · FEI: 3012818475 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    34

    Registration Details

    Registration Name
    Device Innovation Company Limited
    Registration Number
    3012818475
    FEI Number
    3012818475
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    33/333 Soi Ngamwongwan 47 Yak 12 (Chinnakhet 2/10) Tungsonghong Laksi
    City
    Bangkok Krung Thep Maha Nakhon
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K221396

    Owner / Operator

    Firm Name
    Device Innovation Company Limited
    Operator Number
    10085496
    Address
    333/361 Soi Prachachuen 10 (Garden City Lagoon Village) Tungsonghong Laksi
    City
    Bangkok
    State
    TH-NOTA
    Postal Code
    10210
    Country
    TH

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Finger Cot LZB
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Accessories, Arthroscopic NBH
    Arthroscope HRX
    Laparoscope, General & Plastic Surgery GCJ
    Bur, Surgical, General & Plastic Surgery GFF
    Punch, Surgical LRY
    Pin, Fixation, Smooth HTY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Washer, Bolt Nut HTN
    Component, Traction, Non-Invasive KQZ
    Camera, Television, Surgical, Without Audio FWB
    Gauge, Depth HTJ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Bit, Drill HTW
    Staple, Fixation, Bone JDR
    Probe HXB
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Shoulder Prosthesis, Reverse Configuration PHX
    Apparatus, Traction, Non-Powered HST
    Instrument, Manual, Surgical, General Use MDM
    Camera, Surgical And Accessories KQM
    Protector, Skin Pressure FMP
    Orthopedic Manual Surgical Instrument LXH
    Table And Attachments, Operating-Room BWN

    Proprietary Names

    INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Accessories, Arthroscopic Bur, Surgical, General & Plastic Surgery PUNCH, SURGICAL COMPONENT, TRACTION, NON-INVASIVE CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO GAUGE, DEPTH CMC MINI TIGHTROPE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE LOW PROFILE PLATE AND SCREW SYSTEM BIT, DRILL Plates, Screws, and Staples Probe BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL fastener, fixation, nondegradable, soft tissue Finger cot Apparatus, Traction, Non-Powered KNOTLESS FIBERTAK SUTURE ANCHOR Instrument, Manual, Surgical, General Use CAMERA, SURGICAL AND ACCESSORIES Protector, Skin Pressure Orthopedic Manual Surgical Instrument LOW PROFILE SCREWS Table And Attachments, Operating-Room

    Establishment Types

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