BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Berkeley Advanced Biomaterials

    Reg #: 3014211822 · FEI: 3014298539 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Berkeley Advanced Biomaterials
    Registration Number
    3014211822
    FEI Number
    3014298539
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2800 Seventh Street
    City
    Berkeley
    State
    CA
    ZIP
    94710
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091912

    Owner / Operator

    Firm Name
    Berkeley Advanced Biomaterials
    Operator Number
    9049267
    Address
    2800 Seventh Street, --
    City
    Berkeley
    State
    CA
    Postal Code
    94710
    Country
    US
    Correspondent
    Mesfin W Mengesha

    Products

    Device Name Product Code
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Filler, Bone Void, Calcium Compound MQV
    Methyl Methacrylate For Cranioplasty GXP

    Proprietary Names

    B-GENIN and R-GENIN Cem-Ostetic Putty Injection Kit Bi-O Plus Bi-Ostetic GenerOs Foam, Tri-Ostetic Foam Bi-Ostetic Foam, Cem-Ostetic Foam Cem-Ostetic Bone;CemO-10G,CemO-20G Bi-Ostetic Bioactive Glass Foam OsteoMatrix Bi-Ostetic Foam and Putty NexGraft EvoGraft OptiFuse Cem-Ostetic, CemO-20P,CemO-05P B-GENIN, R-GENIN

    Establishment Types

    Manufacture Medical Device