BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Bio2 CLM BG Bioactive Scaffold

    K Number: K152589 · Decision Jan 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    3
    Review Days
    124

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Bio2 CLM BG Bioactive Scaffold
    K Number
    K152589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio2 Technologies, Inc.
    Date Received
    September 10, 2015
    Decision Date
    January 12, 2016
    Product Code
    MQV
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQV), ordered by most recent decision date.

    Device 300419 Strip

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JAZBI™ Resorbable Bone Void Filler

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Adaptos®Fuse Bone Graft

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Bio2 Technologies, Inc.

    K Number Device Name
    K151876 Bio2 Fusion Implant System
    K142463 Bio2 CLM BG Bioactive Scaffold