BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    ELITE SURGICAL SUPPLIES (PTY) LTD

    Reg #: 3005325790 · FEI: 3005325790 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    ELITE SURGICAL SUPPLIES (PTY) LTD
    Registration Number
    3005325790
    FEI Number
    3005325790
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    54 De Havilland Crescent, Persequor Technopark, Persequor
    City
    Pretoria Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K063453

    Owner / Operator

    Firm Name
    Elite Surgical Supplies (Pty) Ltd
    Operator Number
    10025504
    Address
    54 De Havilland Crescent,, Persequor Technopark
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0020
    Country
    ZA
    Correspondent
    Rudi Verbeek

    US Agent

    Business Name
    JALEX Medical LLC
    Contact Name
    Jennifer Palinchik
    Address
    27865 Clemens Rd, Suite #3
    City
    Westlake
    State
    OH
    ZIP
    44145
    Country
    US
    Email
    [email protected]
    Phone
    440 5410060

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Tape, Measuring, Rulers And Calipers FTY
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Tray, Surgical, Instrument FSM
    Template HWT
    Kit, Surgical Instrument, Disposable KDD
    Caliper KTZ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Instrument, Surgical, Disposable KDC

    Proprietary Names

    Vertefix Spinal System VMS ANGLED RULER Biolign STACC Biolign TLIF Biolign ACIF Vertical Measurement System (VMS) Re-usable Tray VMS Template - Left Anterior Aiming Device VMS Template - Right Posterior Aiming Device VMS Template - Right Anterior Aiming Device VMS Template - Left Posterior Aiming Device Vertical Measurement System (VMS) Right Posterior Vertical Measurement System (VMS) Left Anterior Vertical Measurement System (VMS) Left Posterior Vertical Measurement System (VMS) Right Anterior VMS FEMORAL GAUGE Biolign Rotoloc VMS Right Posterior Aiming Device VMS Left Posterior Aiming Device VMS Left Anterior Aiming Device VMS Right Anterior Aiming Device

    Establishment Types

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