BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BEAR® (Bridge-Enhanced ACL Repair) Implant

    Reg #: 3020652309 · FEI: 3020652309 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MIACH ORTHOPAEDICS
    Registration Number
    3020652309
    FEI Number
    3020652309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    69 Milk Street, Suite 100
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243578

    Owner / Operator

    Firm Name
    Miach Orthopaedics
    Operator Number
    10082865
    Address
    69 Milk Street, Suite 100
    City
    Westborough
    State
    MA
    Postal Code
    01581
    Country
    US
    Correspondent
    Gregory DeVenne

    Products

    Device Name Product Code
    Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair QNI

    Proprietary Names

    BEAR® (Bridge-Enhanced ACL Repair) Implant

    Establishment Types

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