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

    Biopor, AOC Porous Polyethylene, Cerepor

    K Number: K160988 · Decision Jul 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    20
    Review Days
    97

    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
    Biopor, AOC Porous Polyethylene, Cerepor
    K Number
    K160988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ceremed , Inc.
    Date Received
    April 8, 2016
    Decision Date
    July 14, 2016
    Product Code
    KKY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

    Similar 510(k) Clearances

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

    Longeviti PorousFit implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OsteoFab Patient Specific Facial Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOPOR AOC POROUS POLYETHYLENE, CEREPOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SU-POR SURGICAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OMNIPORE CUSTOMIZED SURGICAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Ceremed , Inc.

    K Number Device Name
    K161446 Biopor Porous Polyethylene Implants
    K141880 BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
    K132198 ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
    K122561 ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
    K120220 ADAPTAIN SOLUBLE IMPLANT MATERIAL
    K103047 CERETENE SOLUBLE IMPLANT MATERIAL
    K102071 OSTENE CT, AOC CT, OSTEOTENE, CERETENE
    K091636 OSTENE CT, AOC CT, OSTEOTENE, CERETENE
    K082491 OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
    K082245 AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
    Search all 20 clearances from Ceremed , Inc. →