BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOVENTUS LLC

    Reg #: 3009595577 · FEI: 3009595577 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    BIOVENTUS LLC
    Registration Number
    3009595577
    FEI Number
    3009595577
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4721 Emperor Blvd Ste 100
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142432
    PMA Number
    P170007

    Owner / Operator

    Firm Name
    Bioventus LLC
    Operator Number
    10040666
    Address
    4721 Emperor Blvd., Suite 100
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Kellie Stefaniak

    Products

    Device Name Product Code
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Filler, Bone Void, Calcium Compound MQV
    Acid, Hyaluronic, Intraarticular MOZ
    Syringe, Piston FMF
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep LPQ
    Stimulator, Bone Growth, Non-Invasive LOF

    Proprietary Names

    StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit StimRouter Plus OSTEOMATRIX+ OsteoMatrix DUROLANE StimRouter Neuromodulation System Osteoamp Flowable Access Cannula SIGNAFUSE Bioactive Strip TalisMann Neuromodulation System Interface Signafuse Osteofuse Unite StimTrial Neuromodulation System Silhouettte EXOGEN EXPRESS EXOGEN 4000J EXOGEN SAFHS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198