BEUDAMED
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    Double ENDOBUTTON Fixation Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304438880·

    SONTEC SLIM THERMOPLASTIC INSTRUMENT TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019409·SONTEC SLIM THERMOPLASTIC INSTRUMENT TRAY WITH ...

    MODIFICATION TO:MICROFUSE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CASPIAN SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD UNKNOWN KNEE PATELLA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018

    VANGUARD CR FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018

    BIOMET CC I-BEAM TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018

    WHITESTAR SIGNATURE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HQC·October 17, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 21, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 28, 2011

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024