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

    Renovis Surgical Hip Replacement System

    K Number: K171543 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    174

    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
    Renovis Surgical Hip Replacement System
    K Number
    K171543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovis Surgical Technologies
    Date Received
    May 26, 2017
    Decision Date
    November 16, 2017
    Product Code
    OQG
    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
    OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

    Similar 510(k) Clearances

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

    Prime and DYNASTY® Additive Manufacturing Shells

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMTI Hip Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FMP Extended Liners

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

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

    Other Clearances by Renovis Surgical Technologies

    K Number Device Name
    K190122 Renovis A200 PS Knee System as part of the Renovis A200 Knee System
    K182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
    K181655 Renovis S180 Lateral Lumbar Interbody Fusion System
    K170888 Renovis S141 Lumbar Interbody Fusion System
    K153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
    K143126 Renovis S141 Lumbar Interbody Cage System