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

    UNIVATION UNICONDYLAR KNEE SYSTEM

    K Number: K081293 · Decision Sep 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    22
    Review Days
    138

    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
    UNIVATION UNICONDYLAR KNEE SYSTEM
    K Number
    K081293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, Inc.
    Date Received
    May 7, 2008
    Decision Date
    September 22, 2008
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

    Similar 510(k) Clearances

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

    SIGMA High Performance (HP) Partial Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NanoOrtho NanoKnee® System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MPO Total Knee Systems MR Labeling

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORIS POROUS PARTIAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVATION

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

    Other Clearances by Aesculap Implant Systems, Inc.

    K Number Device Name
    K153629 ArcadiusXP C Spinal System
    K132421 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
    K123939 S4 SPINAL SYSTEM
    K123352 S4 SPINAL SYSTEM
    K111122 AESCULAP SIBD XP SPINAL SYSTEM
    K103284 LAMINOPLASY PLATING SYSTEM
    K100802 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
    K092143 EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
    K083004 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
    K083311 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
    Search all 22 clearances from Aesculap Implant Systems, Inc. →