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

    ULTIMA AUGMENTED UHMWPE CUP

    K Number: K950563 · Decision Jun 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    206
    Review Days
    119

    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
    ULTIMA AUGMENTED UHMWPE CUP
    K Number
    K950563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    February 8, 1995
    Decision Date
    June 7, 1995
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

    Similar 510(k) Clearances

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

    Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoRemedies Hip Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InterSpace GV Hip Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPAL® exchange G hip spacer; COPAL® G+V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UHR Bipolar Implants, Restoration GAP II Implants

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

    Other Clearances by Johnson & Johnson Professionals, Inc.

    K Number Device Name
    K992173 SIPHONGUARD CSF CONTROL DEVICE
    K991413 CODMAN ETHISORB DURA PATCH
    K991222 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
    K982379 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    K982812 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    K983141 CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
    K983014 SUMMIT ACETABULAR SYSTEM
    K980778 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
    K974739 HAKIM PROGRAMMABLE VALVE SYSTEM
    K980801 J-FX BIPOLAR HEAD
    Search all 206 clearances from Johnson & Johnson Professionals, Inc. →