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

    ARC-2F ACETABULAR CUP

    K Number: K893785 · Decision Aug 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    80
    Applicant Total
    25
    Review Days
    79

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    Basic Information

    Device Name
    ARC-2F ACETABULAR CUP
    K Number
    K893785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Protek, Inc.
    Date Received
    May 22, 1989
    Decision Date
    August 9, 1989
    Product Code
    LWJ
    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
    LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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    Other Clearances by Protek, Inc.

    K Number Device Name
    K893959 P.S.A. FEMORAL HIP PROSTHESIS
    K892059 FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
    K883794 RESUBMITTED CLW ACETABULAR CUP W/SULMESH
    K884952 VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
    K884889 MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
    K884789 NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
    K890054 M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
    K884888 MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
    K882671 SAMUELSON SCREWLOC CUP
    K874093 SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
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