BEUDAMED
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    Spectra-System®/ Legacy™ Guided Surgery Handle Kit

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307119210·

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 27, 2017

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 15, 2017

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·September 20, 2017

    ATTUNE TIBIAL DRILL TOWER

    FDA Adverse Event
    Malfunction ·DEPUY IRELAND - 9616671·Product code HWT·January 13, 2026

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code LXH·June 26, 2017

    MIKRO 120

    FDA Adverse Event
    Malfunction ·A. HETTICH GMBH & CO. KG.·Product code GHK·March 23, 2010

    LH SLIDE STAINER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GHK·September 14, 2011

    MIKRO 120

    FDA Adverse Event
    Other ·A. HETTICH GMBH & CO. KG·Product code GHK·June 21, 2011

    STAT 60

    FDA Adverse Event
    Malfunction ·SEPARATION TECHNOLOGY·Product code GHK·November 21, 1997

    QBC AUTOREAD PLUS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO·Product code GHK·November 5, 1997

    Centrifuge, Microsedimentation

    FDA classification
    FDA Class 1 ·Centrifuge, Microsedimentation

    GHL LLC

    FDA registration
    GHL LLC·1 product·🇰🇷 South Korea

    BHK-21

    FDA 510(k)
    FDA Class 1 ·Hematology

    Intuitive Surgical G.K.

    FDA registration
    Intuitive Surgical G.K.·16 products·🇯🇵 Japan

    Zimmer Biomet G.K.

    FDA registration
    Zimmer Biomet G.K.·46 products·🇯🇵 Japan

    GHL CO., LTD.

    FDA registration
    GHL CO., LTD.·2 products·🇰🇷 South Korea

    Arthrex Japan G.K. (Shinjuku)

    FDA registration
    Arthrex Japan G.K. (Shinjuku)·31 products·🇯🇵 Japan

    Medline Logistics Japan G.K.

    FDA registration
    Medline Logistics Japan G.K.·1 product·🇯🇵 Japan

    by Humankind

    FDA UDI
    By Humankind, Inc.·00850007634483·By Humankind, BHK-DV1 Product Profile: The ref...