BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VersaTip Percutaneous Suture Passer Handle, Reusable

    Reg #: 3021286087 · FEI: 3021286087 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    TENSOR SURGICAL, INC.
    Registration Number
    3021286087
    FEI Number
    3021286087
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6345 S Pecos Rd Ste 212
    City
    Las Vegas
    State
    NV
    ZIP
    89120
    Country
    US

    Owner / Operator

    Firm Name
    Tensor Surgical, Inc.
    Operator Number
    10083936
    Address
    6345 S Pecos Rd Ste 212
    City
    Las Vegas
    State
    NV
    Postal Code
    89120
    Country
    US
    Correspondent
    Justin Anderson

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    VersaTip Percutaneous Suture Passer Handle, Reusable TransOs Suture Fixation Implant and VersaTip System 4021 TransOs Tunneler Inner Shaft (component) #2 Implantable HS-Fiber Suture, 12/Box VersaTip Suture Passer Tip, 40 degree Left, 5/box VersaTip Suture Passer Tip, 20 degree Right, 5/box TransOs Tunneler Handle (component) TransOs SutureTape Fixation Implant System 5040 TransOs Tunneler Shoulder Pro VersaTip Suture Passer Handle, Reusable VersaTip Suture Passer Tip, 40 degree Right, 5/box TransOs Tunneler Medial Awl w/Microfracture Tip #2 Implantable HS-Fiber® Suture, 3 strands, 12/Box TransOs SutureTape Fixation Implant System 5020 VersaTip Percutaneous Suture Passer Tip, Straight, 5/box VersaTip Suture Passer Tip, Crescent, 5/box TransOs Tunneler Awl Inserter, Individual TransOs Tunneler Nut (component) TransOs Tunneler Shoulder Pro Instrument Set VersaTip Suture Passer Tip, 20 degree Left, 5/box TransOs Tunneler Thumb Knob (component) TransOs Suture Fixation Implant System 4040 TransOs Tunneler Outer Shaft Hook Tip - Shoulder (component) VersaTip Hip Suture Passer Handle, Reusable VersaTip Percutaneous Suture Passer Tip, 30 degree Retrograde, 5/box VersaTip Suture Passer Tip, 60 degree Retrograde, 5/box VersaTip Suture Passer Snare, 5/box VersaTip Hip Suture Passer Tip, 60 degree Retrograde, 5/box VersaTip Suture Passer Tip, 30 degree Retrograde, 5/box TransOs Suture Fixation Implant System 4020 TransOs Suture Organizers, Reusable, 10/Box 1.4mm Implantable HS SutureTape, 3 strands, 12/Box VersaTip Hip Suture Passer Tip, 30 degree Retrograde, 5/box Shogun Suture Passer TransOs SutureTape Fixation Implant System 5010

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device