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

    METHA HIP SYSTEM

    K Number: K112682 · Decision Mar 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    22
    Review Days
    186

    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
    METHA HIP SYSTEM
    K Number
    K112682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems, LLC
    Date Received
    September 15, 2011
    Decision Date
    March 19, 2012
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    Similar 510(k) Clearances

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

    Z1 Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Avenir® Müller Stem; Avenir Complete™ Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    implantcast Packaging System Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    implaFit® short stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Coated hip implants

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

    Other Clearances by Aesculap Implant Systems, LLC

    K Number Device Name
    K213871 Ennovate Cervical Spinal and Occiput System
    K210963 ENNOVATE Spinal System
    K180433 ENNOVATE®
    K162134 ENNOVATE Spinal System
    K153700 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
    K153396 Aesculap OrthoPilot Next Generation
    K151938 S4 Cervical Spinal and Occiput Systems
    K151056 Aesculap T-Space PEEK and XP Spinal System
    K150544 Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
    K141694 AESCULAP ORTHOPILOT NEXT GENERATION
    Search all 22 clearances from Aesculap Implant Systems, LLC →