BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    InSpace™ US Large

    Reg #: 3016573902 · FEI: 3016573902 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Ortho-Space Ltd.
    Registration Number
    3016573902
    FEI Number
    3016573902
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 Halamish St
    City
    Caesarea Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    DEN200039

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    US Agent

    Business Name
    Stryker Endoscopy
    Contact Name
    April Malmborg
    Address
    5900 Optical Court
    City
    San Jose
    State
    CA
    ZIP
    95138
    Country
    US
    Email
    [email protected]
    Phone
    408 4093115

    Products

    Device Name Product Code
    Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed QPQ

    Proprietary Names

    InSpace™ US Large InSpace™ US Medium InSpace™ US Small

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198