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

    RejuvaKnee™ Collagen Meniscus Implant

    K Number: K242302 · Decision Oct 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    47
    Review Days
    58

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    Basic Information

    Device Name
    RejuvaKnee™ Collagen Meniscus Implant
    K Number
    K242302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Collagen Matrix, Inc.
    Date Received
    August 5, 2024
    Decision Date
    October 2, 2024
    Product Code
    OLC
    Advisory Committee
    General, Plastic Surgery
    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
    OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

    Similar 510(k) Clearances

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

    Collagen Meniscus Implant XL

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

    REGEN COLLAGEN SCAFFOLD (CS)

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

    Other Clearances by Collagen Matrix, Inc.

    K Number Device Name
    K251191 Collagen Dura Regeneration Membrane - Repair
    K243071 Bovine Dermis Collagen Dermal Matrix
    K233203 Soft Tissue Augmentation Resorbable Matrix
    K240424 Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
    K231942 Mineral Collagen Composite Bioactive Extra Moldable
    K221735 Mineral Collagen Composite Bioactive Moldable
    K213341 Fibrillar Collagen Wound Dressing
    K202183 Porcine Mineral Collagen Composite
    K201859 Porcine Mineral Collagen Composite Moldable
    K182074 Mineral Collagen Composite Bioactive Moldable
    Search all 47 clearances from Collagen Matrix, Inc. →