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

    SMC ACETABULAR COMPONENT

    K Number: K971018 · Decision Oct 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    9
    Review Days
    218

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    Basic Information

    Device Name
    SMC ACETABULAR COMPONENT
    K Number
    K971018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signal Medical Corp.
    Date Received
    March 20, 1997
    Decision Date
    October 24, 1997
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Signal Medical Corp.

    K Number Device Name
    K100370 SYMMETRIC TOTAL KNEE AGUMENTS
    K073674 BONE FIXATION WIRE (KIRSCHNER WIRE)
    K051510 SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
    K043289 E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
    K022382 RHS ACETABULAR COMPONENT
    K021063 GREAT TOE IMPLANT
    K981302 SMC 28MM CERAMIC FEMORAL HEADS
    K971681 SMC FEMORAL HIP COMPONENT