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

    Osteorevive

    K Number: K212991 · Decision Jan 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    8
    Review Days
    123

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    Basic Information

    Device Name
    Osteorevive
    K Number
    K212991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bone Solutions, Inc.
    Date Received
    September 20, 2021
    Decision Date
    January 21, 2022
    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

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    Other Clearances by Bone Solutions, Inc.

    K Number Device Name
    K251522 Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
    K242372 Mg OSTEOREVIVE™, Mg OSTEOCRETE™
    K234013 Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
    K221256 Mg OSTEOINJECT
    K192674 Mixing and Delivery System
    K161568 Bone Solutions Mixing and Delivery System
    K071004 OSTEOCRETE BONE VOID FILLER