BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Winter Innovations, Inc.

    Reg #: 3021190802 · FEI: 3021190802 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Winter Innovations, Inc.
    Registration Number
    3021190802
    FEI Number
    3021190802
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7625 Golden Triangle Drive, Suite G
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210675

    Owner / Operator

    Firm Name
    Winter Innovations
    Operator Number
    10083367
    Address
    2450 EJ Chapman Drive, Suite 114
    City
    Knoxville
    State
    TN
    Postal Code
    37996
    Country
    US
    Correspondent
    Lia Winter

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    StitchStand EasyWhip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility