BEUDAMED
    19 results · 74ms · Sources: EU EUDAMED, US FDA

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    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 26, 2019

    X-PAC

    FDA Adverse Event
    Injury ·EXPANDING INNOVATIONS, INC.·Product code MAX·December 22, 2021

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 20, 2020

    UNKNOWN TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 20, 2020

    UNKNOWN POLYETHYLENE LINER

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 20, 2020

    UNKNOWN_SELZACH_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·December 7, 2015

    UNKNOWN_SELZACH_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·December 8, 2015

    UNKNOWN STAR TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSN·December 27, 2019

    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXH·April 1, 2019

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    Wellkang Ltd

    Authorized representative
    259 Manufacturers·3500 Devices

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices