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

    B2C, ESPACE REVISION CUP SYSTEM

    K Number: K990523 · Decision Apr 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    26
    Review Days
    70

    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
    B2C, ESPACE REVISION CUP SYSTEM
    K Number
    K990523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Turnkey Intergration USA, Inc.
    Date Received
    February 19, 1999
    Decision Date
    April 30, 1999
    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

    Similar 510(k) Clearances

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

    iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Taperloc® Complete Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G7® Revision Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mpact 3D Metal Implants Extension – DMLS Technology

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Velora Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TaperSet™ Hip System

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

    Other Clearances by Turnkey Intergration USA, Inc.

    K Number Device Name
    K991405 OMNI-FIX, HUMERAL NAIL
    K990307 OMNI-FIX, NAIL SYSTEM
    K972411 LINK CEMENT PLUG
    K970284 ARTOS, DIPLOS SYSTEM
    K970084 LINK CERCLAGE WIRE SYSTEM
    K953653 LUBINUS SP II HIP SYSTEM
    K943986 LINK ENDO MODEL REVISION CUP
    K951355 LINK SADDLE PROTHESIS
    K950397 SYSTEM 22 VALVE
    K940297 UNIVERSAL WRIST
    Search all 26 clearances from Turnkey Intergration USA, Inc. →