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510(k) Data Aggregation
K Number
K233958Device Name
hekaDrill
Manufacturer
Zethon Ltd
Date Cleared
2024-03-14
(90 days)
Product Code
ERL, GEY, HBB, HBC, HBE, HSZ
Regulation Number
874.4250Why 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
K193630Device Name
hekaDrill
Manufacturer
Zethon Ltd
Date Cleared
2021-04-09
(470 days)
Product Code
HBC, ERL, HBB, HBE, HSZ
Regulation Number
882.4360Why 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.
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