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The Sodem High Speed System includes a pneumatic motor which allows the fixation of spindles, adapters and attachments, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for different applications and surgeries. The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery) applications.

The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) used to cut hard tissue or bone. The Sodem High Speed System (Pneumatic) is a complete system including: - a High Speed motor, - - a foot pedal, - dedicated hoses to connect the motors and the foot pedal, - - adapters (angled adapter) - attachments/spindles, (angled attachments, straight attachments standard and tapered, craniotomes) - drills, burs and cutters

The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries. This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot ... ) applications.

The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic). The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) and especially Drill Guide Attachment used to make holes in the bone with an adjustable depth. The Sodem High Speed System (Pneumatic) is a complete system including: - a High Speed motor, . - . a foot pedal, - dedicated hoses to connect the motor and the foot pedal, - - adapters (angled adapter) - Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes) - drills, burs and cutters - The Sodem High Speed System (Pneumatic) for use in Neurology applications is the same product as the Sodem High Speed System (Pneumatic) already submitted for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174) and currently submitted for ENT and Dental surgery. The difference is the addition of a new attachment PN 3105 DG : Drill Guide Attachment.

The Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone (knee, ankle, hand, foot, facial and maxillary bones) for orthopedics and general plastic surgery. Motor, attachments and cutting tools are for use in general orthopedics and general plastic surgery.

The Sodem High Speed System (Electric) is a complete system including: - two motors (a Skull Perforator motor* and a High Speed motor), - - a foot pedal, - - a console allowing to connect the motors and to select their max. operating speed, - - dedicated wires to connect the motors, the foot pedal and the console, - - attachments/spindles, - - drills, burs and cutters - * This 510(k) doesn't deal with the skull perforator motor because we have submitted a separate 510(k) for neuro/spine applications. The motor is to be attached to the Sodem High Speed console and is operated with a foot pedal. The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.

The Sodem High Speed motor allows the fixation of spindles and craniotomes, which opcrate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones. The Sodom High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodcm, but is available on the market from other manufacturers. Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.

The Sodem High Speed System (Electric) is a complete system including: - two motors (a Skull Perforator motor and a High Speed motor), - - a foot pedal, - - a console allowing to connect the motors and to select their max. operating speed, - - dedicated wires to connect the motors, the foot pedal and the console - - attachments/spindles and craniotomes - - drills, burs and cutters - The motors are to be attached to the Sodem High Speed console and are operated with a foot pedal. The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.

The Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for ear, nose and throat surgery. Motor, attachments and cutting tools are for use in ear, nose and throat surgery.

The Sodem High Speed System (Electric) is a complete system including: - two motors (a Skull Perforator motor* and a High Speed motor), - - a foot pedal, - - a console allowing to connect the motors and to select their max. operating speed, - - dedicated wires to connect the motors, the foot pedal and the console, - - ー. attachments/spindles, - drills, burs and cutters - * A separate 510(k) Premarket Notification has been submitted for neurolspine surgery, so on this 510(k) submission, we will cover only the High Speed Motor and its use in ear, nose and throat surgery. The motor is to be attached to the Sodem High Speed console and is operated with a foot pedal. The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601. The Sodem High Speed System (Electric) is very similar in terms of use and technological characteristics to products currently on the market (TPS from Stryker and E9000 / Advantage from Linvatec). Also, the Sodem High Speed System (Electric) is equivalent in terms of use with the Sodem High Speed System (Pneumatic) already submitted (K954717).

The Sodem High Speed System (with associated accessories/attachments) is intended for use for neuro surgery (spine and craniatomy) and median sternotomy.

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