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510(k) Data Aggregation

    K Number
    K233958
    Device Name
    hekaDrill
    Manufacturer
    Zethon Ltd
    Date Cleared
    2024-03-14

    (90 days)

    Product Code
    ERL, GEY, HBB, HBC, HBE, HSZ
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zethon Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures.
    Device Description
    The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.
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    K Number
    K193630
    Device Name
    hekaDrill
    Manufacturer
    Zethon Ltd
    Date Cleared
    2021-04-09

    (470 days)

    Product Code
    HBC, ERL, HBB, HBE, HSZ
    Regulation Number
    882.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zethon Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in Neurologic and general surgical procedures.
    Device Description
    The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.
    Ask a Question

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