BEUDAMED
    Product Code: JOF FDA class 2 21 CFR 874.3620

    Polymer, Ent Synthetic, Porous Polyethylene

    Ear, Nose, Throat

    The Polymer, ENT Synthetic, Porous Polyethylene is a biomaterial implant used in ear, nose, and throat reconstructive surgery, fabricated from porous high-density polyethylene to provide a biocompatible scaffold for soft tissue and bone ingrowth in craniofacial and otolaryngological reconstruction procedures. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JOF and is regulated under 21 CFR 874.3620, within the Ear, Nose, and Throat medical specialty. This device is an implant.

    View on FDA
    510(k)s
    6
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    4
    Years Active
    43

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    Basic Information

    Product Code
    JOF
    Device Class
    FDA class 2
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K200532 StarPore
    K171037 PoreStar Patient Specific Implant
    K083621 MEDPOR CUSTOMIZED SURGICAL IMPLANT
    K002629 SILMAX CONTOUR CARVING BLOCK IMPLANT
    K771727 BIOSPONGE RECONSTRUCTION DISCS
    K771726 BIOSPONGE STAPES PISTON

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.