BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5.5mm V-LoX Titanium Suture Anchor w/Needles

    Reg #: 1064017 · FEI: 3000190635 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AME INT'L.
    Registration Number
    1064017
    FEI Number
    3000190635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7440 SOUTH WEST 50 TERR., No. 108
    City
    MIAMI
    State
    FL
    ZIP
    33155
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090075

    Owner / Operator

    Firm Name
    AME INT'L.
    Operator Number
    9036247
    Address
    7440 SOUTH WEST 50 TERR., #108, --
    City
    Miami
    State
    FL
    Postal Code
    33155
    Country
    US
    Correspondent
    VICTOR - FERNANDEZ

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC

    Proprietary Names

    5.5mm V-LoX Titanium Suture Anchor w/Needles 5.5mm V-LoX3 Titanium Suture Anchor 5mm V-LoX Titanium Suture Anchor 6.5mm V-LoX3 Titanium Suture Anchors 5.5mm V-LoX Titanium Suture Anchor 4.5mm V-LoX Titanium Suture Anchor 4.5mm V-LoX Titanium Suture Anchor w/Needles 6.5mm V-LoX Titanium Suture Anchor 6.5mm V-LoX Titanium Suture Anchor w/Needles 5mm V-LoX Titanium Suture Anchor w/Needles

    Establishment Types

    Repack or Relabel Medical Device