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

    C FIT CUP

    K Number: K903938 · Decision Jan 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    95
    Review Days
    130

    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
    C FIT CUP
    K Number
    K903938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Orthopedic Systems, Inc.
    Date Received
    August 27, 1990
    Decision Date
    January 4, 1991
    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 Orthopedic Systems, Inc.

    K Number Device Name
    K952495 ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
    K920256 SPINE MOTION ANALYZER WITH EMG
    K910736 JACKSON MULTIPURPOSE OPERATING TABLE
    K910031 PARK CITY SHOULDER POSITIONER
    K892503 NUFFIELD TOTAL KNEE
    K896678 SILICONE PLUG
    K894283 COMPREHENSIVE SPINE MOTION ANALYZER
    K890498 FREEMAN MODULAR HIP STEM RIDGED VERSION
    K890331 FREEMAN TOTAL HIP SYSTEM RIDGED STEM
    K895217 CORTICAL SCREW
    Search all 95 clearances from Orthopedic Systems, Inc. →