BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    JOINSMART BIOMEDICAL CO., LTD.

    Reg #: 3015539532 · FEI: 3015539532 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    JOINSMART BIOMEDICAL CO., LTD.
    Registration Number
    3015539532
    FEI Number
    3015539532
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room A, 9F, No. 351, Xingshan Rd.
    City
    Tapei Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K180594

    Owner / Operator

    Firm Name
    Joinsmart Biomedical Co., Ltd.
    Operator Number
    10084852
    Address
    Room A, 9F, No. 351, Xingshan Rd.
    City
    Tapei
    State
    Taipei
    Postal Code
    11469
    Country
    TW

    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
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Washer, Bolt Nut HTN
    Component, Traction, Non-Invasive KQZ
    Arthroscope HRX
    Reamer HTO
    Bit, Drill HTW
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Screw, Fixation, Bone HWC
    Table And Attachments, Operating-Room BWN
    Instrument, Manual, Surgical, General Use MDM
    Pin, Fixation, Smooth HTY
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Laparoscope, General & Plastic Surgery GCJ
    Orthopedic Manual Surgical Instrument LXH
    Syringe, Piston FMF
    Staple, Fixation, Bone JDR
    Apparatus, Traction, Non-Powered HST
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Accessories, Arthroscopic NBH

    Proprietary Names

    Mini Tightrope Component, Traction, Non-Invasive Reamer Bit, Drill SutureTape Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment MENISCAL CINCH Table And Attachments, Operating-Room Instrument, Manual, Surgical, General Use Blade, Saw, General & Plastic Surgery, Surgical Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Orthopedic Manual Surgical Instrument Apparatus, Traction, Non-Powered Accessories, Arthroscopic PCL TIGHTROPE

    Establishment Types

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