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

    BONE CEMENT FOR CRANIOPLASTY

    K Number: K040152 · Decision May 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    32
    Review Days
    117

    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
    BONE CEMENT FOR CRANIOPLASTY
    K Number
    K040152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinalhealth
    Date Received
    January 23, 2004
    Decision Date
    May 19, 2004
    Product Code
    GXP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXP Methyl Methacrylate For Cranioplasty

    Similar 510(k) Clearances

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

    Permatage XT Settable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    Permatage Flowable, Settable Bone Paste

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONTAGE XT Cranial Cement

    FDA 510(k)
    FDA Class 2 ·Neurology

    Permatage Settable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    Montage Flowable Settable, Resorbable Bone Paste

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONTAGE-QS Settable, Resorbable Bone Putty

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

    Other Clearances by Cardinalhealth

    K Number Device Name
    K252313 Cardinal Health Nitrile Examination Gloves Extended Cuff
    K243660 Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
    K243652 Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)
    K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
    K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
    K202217 Kendall NPWT Incision Management Device
    K191101 Kendall NPWT Incision Management Dressing Kit
    K190923 Salem Sump Dual Lumen Stomach Tube with ENFit Connection
    K171499 Occlusion Detection Dressing Kit
    K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
    Search all 32 clearances from Cardinalhealth →