BEUDAMED
    FDA Registration Active 🇫🇷 France

    TORNIER S.A.S

    Reg #: 3008388276 · FEI: 3008388276 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    TORNIER S.A.S
    Registration Number
    3008388276
    FEI Number
    3008388276
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    176 RUE LAVOISIER
    City
    Montbonnot Saint-Martin Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K111902

    Owner / Operator

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

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Arthroplasty Implantation System QHE
    Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis QKW

    Proprietary Names

    Aequalis Shoulder System Tornier Perform Anatomic Glenoid Aequalis Ascend Flex Titanium Head Blueprint BLUEPRINT Patient Specific Instrumentation Tornier Flex Shoulder System Aequalis" Ascend" Flex Shoulder System Aequalis Ascend Flex Shoulder System Aequalis Reversed Shoulder Prosthesis AEQUALIS REVERSED SHOULDER PROSTHESIS Aequalis Reversed II - Threaded Post Baseplate Aequalis Ascend FLEX Shoulder System Tornier Pyrocarbon Humeral Head Blueprint™ Patient Specific Instrumentation Tornier Perform™ Patient-Matched Primary Reversed Glenoid Shoulder iD™ Shoulder iD™ Primary Reversed Glenoid Aequalis Reversed Titanium Glenoid Sphere

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198