BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    Biolign STACC

    Reg #: 3005325790 · FEI: 3005325790 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ELITE SURGICAL SUPPLIES (PTY) LTD
    Registration Number
    3005325790
    FEI Number
    3005325790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    54 De Havilland Crescent, Persequor Technopark, Persequor
    City
    Pretoria Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K130274

    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
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE

    Proprietary Names

    Biolign STACC Biolign TLIF Biolign ACIF

    Establishment Types

    Manufacture Medical Device