BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAINSTREAM MEDICAL DEVICES

    Reg #: 3016112537 · FEI: 3016112537 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    33
    Establishment Types
    4
    Classifications
    30

    Registration Details

    Registration Name
    MAINSTREAM MEDICAL DEVICES
    Registration Number
    3016112537
    FEI Number
    3016112537
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3913 Todd Lane, Suites 304; 112
    City
    Austin
    State
    TX
    ZIP
    78744
    Country
    US

    Owner / Operator

    Firm Name
    Mainstream Medical Devices
    Operator Number
    10061802
    Address
    3913 Todd Lane, Suite 304
    City
    Austin
    State
    TX
    Postal Code
    78744
    Country
    US
    Correspondent
    Dana Wilcox

    Products

    Device Name Product Code
    Gauge, Depth HTJ
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Awl HWJ
    Catheter Introducer Kit OFC
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Bit, Drill HTW
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Sacroiliac Joint Fixation OUR
    Pin, Fixation, Smooth HTY
    Retractor GAD
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthopedic Manual Surgical Instrument LXH
    Instruments, Dental Hand DZN
    Laparoscope, General & Plastic Surgery GCJ
    Screwdriver HXX
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Instrument, Manual, Surgical, General Use MDM
    Cannula, Surgical, General & Plastic Surgery GEA
    Knife, Surgical EMF
    Spinous Process Plate PEK
    Chisel, Surgical, Manual FZO
    Mallet HXL
    Rongeur, Manual HAE
    Arthroscope HRX
    Percutaneous Introducer Kit PXB

    Proprietary Names

    Diamond Orthopedic Solar Mainstream Prytime HyperFlex Bunion Correction System Main-AXS Needle Leith Medical Impulse AM DeGen Medical Latitude C T-Fix 3Dsi VariLift Carlsmed Thoracic Innovations BlueBridge Open Chest Management System EVOLSi Elevation Spine Saber-C System Bone Solutions Spinal Simplicity Minuteman Graduated Tap Spinal Simplicity Patriot SI Posterior SI Joint Fusion Kit Get-Grin ClearCam Footbridge Medical HyperFlex Bunion Correction System Sterile Drill Bit - RMR Sterile Drill Bit VGI Medical SiJoin Baumann GRS Mainstream Medical Surgical Knife primal OK SP Tightline E3D-A Interbody System Main-Mallet Varilift TransLoc 3D Freedom DS Decompression System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)