BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CM-6255 BioWick X Implant (PEEK), 5.5mm Implant Pre-loaded with (2) size 2 UHMWPE Suture Strands

    Reg #: 2031093 · FEI: 3001236549 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LIFE SCIENCE OUTSOURCING, INC.
    Registration Number
    2031093
    FEI Number
    3001236549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    830 Challenger Street
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172186

    Owner / Operator

    Firm Name
    Life Science Outsourcing, Inc.
    Operator Number
    10024857
    Address
    830 Challenger Street
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Mireya Lozano

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    CM-6255 BioWick X Implant (PEEK), 5.5mm Implant Pre-loaded with (2) size 2 UHMWPE Suture Strands CM-6265 BioWick X Implant (PEEK), 6.5mm Implant Pre-loaded with (3) Size 2 UHMWPE Suture Strands CM-6201 HWX, Tap, for 5.5mm BioWick X Implant CM-6202 HWX, Tap, for 6.5mm BioWick X Implant

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)