BEUDAMED
    FDA Registration Active 🇵🇦 Panama

    ORTOSISTEMAS, S.A.

    Reg #: 3012329552 · FEI: 3012329552 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    37

    Registration Details

    Registration Name
    ORTOSISTEMAS, S.A.
    Registration Number
    3012329552
    FEI Number
    3012329552
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle Elida Diez, Urbanizacion El Carmen. Bella Vista
    City
    Panama
    Country
    PA

    Regulatory Submissions

    510(k) Number
    K200068

    Owner / Operator

    Firm Name
    Ortosistemas, S.A.
    Operator Number
    10083460
    Address
    Calle Elida Diez, Urbanizacion El Carmen. Bella Vista
    City
    Panama
    State
    PA-8
    Postal Code
    238-0816
    Country
    PA

    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
    Pin, Fixation, Smooth HTY
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Screw, Fixation, Bone HWC
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Washer, Bolt Nut HTN
    Staple, Fixation, Bone JDR
    Syringe, Piston FMF
    Arthroscope HRX
    Cerclage, Fixation JDQ
    Plate, Fixation, Bone HRS
    Camera, Surgical And Accessories KQM
    Accessories, Arthroscopic NBH
    Rod, Fixation, Intramedullary And Accessories HSB
    Instrument, Manual, Surgical, General Use MDM
    Protector, Skin Pressure FMP
    Light, Surgical, Fiberoptic FST
    Component, Traction, Non-Invasive KQZ
    Filler, Bone Void, Calcium Compound MQV
    Apparatus, Traction, Non-Powered HST
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Bit, Drill HTW
    Suture, Nonabsorbable, Silk GAP
    Gauge, Depth HTJ
    Table And Attachments, Operating-Room BWN
    Orthopedic Manual Surgical Instrument LXH
    Reamer HTO
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Camera, Television, Surgical, Without Audio FWB
    Bur, Surgical, General & Plastic Surgery GFF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
    Blade, Saw, General & Plastic Surgery, Surgical GFA

    Proprietary Names

    Camera, Surgical And Accessories accessories, arthroscopic Arthrex Low Profile Screws instrument, manual, surgical, general use protector, skin pressure component, traction, non-invasive apparatus, traction, non-powered Arthrex Synergy Vision Endoscopic Imaging System Bit, Drill gauge, depth Table And Attachments, Operating-Room Orthopedic manual surgical instrument. Reamer centrifuges (micro, ultra, refrigerated) for clinical use camera, television, surgical, without audio bur, surgical, general & plastic surgery Arthrex FastThread Interference Screw blade, saw, general & plastic surgery, surgical

    Establishment Types

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