BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioSphere Putty Bioactive Bone Graft

    Reg #: 3010258202 · FEI: 3010258202 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SYNERGY BIOMEDICAL
    Registration Number
    3010258202
    FEI Number
    3010258202
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    565 E. Swedesford Rd, Suite 310
    City
    Wayne
    State
    PA
    ZIP
    19087
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140844

    Owner / Operator

    Firm Name
    Synergy Biomedical
    Operator Number
    10044250
    Address
    565 E. Swedesford Rd, Suite 310
    City
    Wayne
    State
    PA
    Postal Code
    19087
    Country
    US
    Correspondent
    Matt Brown

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    BioSphere Putty Bioactive Bone Graft

    Establishment Types

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