Device Description : Allen key 3.5 mm is a hand-held instrument used to hold or unhold screw on the e Allen key 3.5 mm is a hand-held instrument used to hold or unhold screw on the extraction clamp and the chisel handle. This is a hexagonal tip of 3.5 mm.This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Extraction clamp is a hand-held instrument, in combination with the slap hammer, Extraction clamp is a hand-held instrument, in combination with the slap hammer, used to extract any femoral implants, as well as any tibial implants. This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Hook, in combination with the slap hammer, is intended to help the surgeon to pu Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberate the components in area where the access, due to soft tissues, is limited. When the instrument is placed at the femoral distal trochlea groove, it is ideal for pulling off the femoral implant. This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held instrument used to, as soon as the femoral implant has been loosed b A hand-held instrument used to, as soon as the femoral implant has been loosed by the chisel blade, for punching out the femoral implant. The extremity is applied proximal onto onto the femoral anterior flange for a stable and safe extraction.This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held instrument used to maintain and hold chisel blade of different desig A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hammer with a mobile mass can be attached to the extraction clamp, as well as A hammer with a mobile mass can be attached to the extraction clamp, as well as on the hook. It permits to give the necessary impact to extract the knee implants. This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A clamp for replacement on the extraction clamp when the blade is damaged. The c A clamp for replacement on the extraction clamp when the blade is damaged. The clamp is symmetric and therefore can be used for either side. The extraction clamp is a hand-held instrument, in combination with the slap hammer, used to extract any femoral implants, as well as any tibial implants.This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A screw for replacement on the extraction clamp when the damaged blade needs to A screw for replacement on the extraction clamp when the damaged blade needs to be replaced by a new clamp. This is a reusable device.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The drills with a transversal pin, permitting the transmission of the torque, ar The drills with a transversal pin, permitting the transmission of the torque, are re-usable rotary cutting instruments used in surgery for drilling cylindrical holes into bone. The cutting action is determined by the cutting edges. A range of diameter and length is proposed.The drills are used with a power tool.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Intramedullary reamer head is used in combination with the Intramedullary reamer Intramedullary reamer head is used in combination with the Intramedullary reamer shaft to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail.The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. A range of diameter is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. The device is reusable.
Device Class : 1
Duns Number: 486741981
Premarket Exempt : Yes
Prescription Use : Yes