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

    APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

    K Number: K101575 · Decision Jun 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
    K Number
    K101575
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnlife Science
    Date Received
    June 7, 2010
    Decision Date
    June 30, 2010
    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 Omnlife Science

    K Number Device Name
    K142201 OMNI Interface Acetabular System
    K112779 APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
    K101994 APEX KNEE MODULAR TIBIA SYSTEM
    K100151 APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
    K073602 MODIFICATION TO: APEX KNEE SYSTEM