BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AME INT'L.

    Reg #: 1064017 · FEI: 3000190635 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    106
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    AME INT'L.
    Registration Number
    1064017
    FEI Number
    3000190635
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7440 SOUTH WEST 50 TERR., No. 108
    City
    MIAMI
    State
    FL
    ZIP
    33155
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090923

    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
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Component, Traction, Non-Invasive KQZ
    Tap, Bone HWX
    Tray, Surgical, Instrument FSM
    Passer, Wire, Orthopedic HXI
    Guide, Surgical, Instrument FZX
    Screwdriver HXX
    Mallet, Surgical, General & Plastic Surgery GFJ
    Awl HWJ
    Stripper, Surgical HRT
    Bit, Drill HTW
    Accessories, Arthroscopic NBH
    Arthroscope HRX
    Passer HWQ
    Orthopedic Manual Surgical Instrument LXH
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Suture, Nonabsorbable, Silk GAP
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW

    Proprietary Names

    Parcus Graft Fixation System Standard and Large 4.5mm V-LoX Titanium Suture Anchor w/Needles 6.5mm V-LoX Titanium Suture Anchor 5.5mm V-LoX Titanium Suture Anchor w/Needles 5mm V-LoX Titanium Suture Anchor w/Needles 6.5mm V-LoX3 Titanium Suture Anchors 5.5mm V-LoX3 Titanium Suture Anchor 4.5mm V-LoX Titanium Suture Anchor 5mm V-LoX Titanium Suture Anchor 5.5mm V-LoX Titanium Suture Anchor 6.5mm V-LoX Titanium Suture Anchor w/Needles PTU - Cross Bar Assembly Parcus PTK Parcus Traction Unit PTU - Pole Plate Assembly PTU - Support Rod Assembly Draw Tight 3.2mm Single Loaded Draw Tight 3.2mm Double Loaded Draw Tight 1.8mm Single Loaded 2mm MiTi Suture Anchor w/ or w/o Needles 3.5mm MiTi Suture Anchor w/ or w/o Needles 2.5mm MiTi Suture Anchor w/ or w/o Needles 5.5-6.5mm Punch/Tap Threaded Dilator Graft Station Tray ACL Tray 2.6mm Trocar Tip Guide Pin w/ Eyelet 1.1mm Nitinol Guide Wire 2.4mm Drill Tip Guide Pin w/ or w/o Eyelet 2.4mm Passing Guide Wire 1.5mm Nitinol Guide Wire 2.4mm Drill Tip Guide Pin w/ Q-Eye Suture Passer Series 3 2.8mm Switching Stick Parcus Pin Pack 15 Parcus Pin Pack 11 Parcus Titanium Interference Screw 45 Knotless PEEK CF Push-In Suture Anchor Driver - Sterile 35 Knotless PEEK CF Push-In Suture Anchor Driver - Reusable Parcus Ratchet Chuck Screwdriver 35 Knotless PEEK CF Push-In Suture Anchor Driver - Sterile 3.5mm Hex w/wo Handle PEEK Screwdriver w/wo handle 45 Knotless PEEK CF Push-In Suture Anchor Driver - Reusable Parcus Braid Suture Parcus PEEK CF Interference Screw PEEK CF Interference Screw Driver w/wo Handle Parcus Mallet 4.5mm Twist PEEK Suture Anchors w/ or w/o Needles 6.5mm Twist PEEK Suture Anchors w/ or w/o Needles 5.5mm Twist PEEK Suture Anchors w/ or w/o Needles 5.5mm Triple Twist PEEK Suture Anchors 6.5mm Triple Twist PEEK Suture Anchors 3.2 Awl with Handle 4.1 Awl with Handle 5.5mm Slotted Tendon Harvester 5.5mm Closed Tendon Harvester 4.75mm Closed Tendon Harvester 4.75mm Slotted Tendon Harvester GFS Mini GFS II 4.5mm V-LoX Hybrid PEEK CF Suture Anchor w/ or w/o Needles Series 3 35 Knotless PEEK CF Push-in Suture Anchor GFS Mini Ultimate GFS Large Ultimate GFS Micro Ultimate 35 Knotless PEEK CF Push-In Suture Anchor 45 Knotless PEEK CF Push-In Suture Anchor 2.8mm, 3mm, 3.2mm, 4mm Unsterile Drill Bits Cannulated Headed Reamer 2.8mm, 3mm, 3.2mm, 4mm Sterile Drill Bits Cannulated Drill 2.8mm, 3mm, 3.2mm, 4mm Reusable Drill Bits V-Mouth Drill Guide 45 Knotless PEEK CF Push-In Suture Anchor Driver Femoral Offset Guides Drill Guide Cannula Drill Tip Guide Pins 35 Knotless PEEK CF Push-In Suture Anchor Driver Parcus Drill Guide (unsterile) Drill Guide Trocar Tip Obturator Drill Guide Blunt Tip Obturator Drill Guide Assembly 8 Point Drill Guide Cobra Tooth Drill Guide Aiming Arm Series 3 35 PEEK CF Push-In Suture Anchor w/ or w/o Needles 5.5mm V-LoX3 PEEK CF Suture Anchor 6.5mm V-LoX3 PEEK CF Suture Anchor 5.5mm V-LoX PEEK CF Suture Anchor 5.5mm V-LoX PEEK CF Suture Anchor w/Needles 6.5mm V-LoX PEEK CF Suture Anchor 6.5mm V-LoX PEEK CF Suture Anchor w/Needles Vista Arthroscopes Suture Passer GFS Naked GFS Depth Gauge Graft Station Prep Board Tibial Bone Plug w/ or w/o Cannulation Graft Sizers GFS Post Graft Grasper and Tensioner Graft Station Fixed Clamp for Graft Station Parcus ACL Set Graft Station Fixed Post Parcus Braid Infinity Loop

    Establishment Types

    Repack or Relabel Medical Device