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

    PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

    K Number: K980817 · Decision Sep 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    25
    Review Days
    206

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    Basic Information

    Device Name
    PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
    K Number
    K980817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interpore Intl.
    Date Received
    March 3, 1998
    Decision Date
    September 25, 1998
    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 Interpore Intl.

    K Number Device Name
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    K960371 INTERPORE THREADED IMPLANT
    K955492 INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
    K952167 IMZ BONE TACK SYSTEM
    K950165 INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
    K922872 INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
    K922732 INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER
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