BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    BIOCOMPOSITES LTD.

    Reg #: 9617083 · FEI: 3002806534 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    BIOCOMPOSITES LTD.
    Registration Number
    9617083
    FEI Number
    3002806534
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KEELE SCIENCE PARK
    City
    Keele Staffordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K141830

    Owner / Operator

    Firm Name
    BIOCOMPOSITES LTD.
    Operator Number
    9032315
    Address
    Keele Science Park, --
    City
    Keele
    State
    Staffordshire
    Postal Code
    ST5 5NL
    Country
    GB
    Correspondent
    Ciara - Airey

    US Agent

    Business Name
    BIOCOMPOSITES, INC.
    Contact Name
    Kathleen Moon
    Address
    SUITE 320, 700 MILITARY CUTOFF ROAD
    City
    WILMINGTON
    State
    NC
    ZIP
    28405
    Country
    US
    Email
    [email protected]
    Phone
    910 3508015 ext. 0

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Template HWT
    Staple, Fixation, Bone JDR
    Screw, Fixation, Bone HWC
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Stimulan Kit Stimulan Rapid Cure Synicem Knee Spacer with Gentamicin Synicem Hip Spacer with Gentamicin Synicem Shoulder Spacer with Gentamicin Allogran-R Fx Fade™ Screw Little Grafter Screw Genex Bone Graft Substtute Genex Putty Genex

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility