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

    PRIME CEMENTED CALCAR FEMORAL STEMS

    K Number: K955620 · Decision Feb 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    8
    Review Days
    71

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PRIME CEMENTED CALCAR FEMORAL STEMS
    K Number
    K955620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orthopaedic Innovations, Inc.
    Date Received
    December 11, 1995
    Decision Date
    February 20, 1996
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.

    Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker Orthopaedics Hip Systems Labeling Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Orthopaedic Innovations, Inc.

    K Number Device Name
    K020145 ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
    K983881 COBRA EXTERNAL FIXATOR
    K962646 PRIME MODULAR ENDO HEAD
    K960014 PRACTIFIX EXTERNAL FIXATION SYSTEM
    K955751 PRIME FEMORAL CEMENT PLUG
    K953033 PRIME CEMENTED SMALL FEMORAL STEM
    K940328 PRIME CEMENTED HIP SYSTEM