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The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Koby Surgical Internal Fixation System consists of a series of cannulated and non-cannulated bone screws which vary in diameters and lengths. These screws are constructed from implant-grade titanium and are used to aid in the fixation of bones in the upper and lower extremities.

The provided document is a 510(k) summary for the Koby Surgical Internal Fixation System, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document is a premarket notification for a medical device seeking substantial equivalence to existing legally marketed devices. It describes the device, its intended use, materials, and classification. The FDA's letter indicates that based on this information, the device is considered substantially equivalent to a predicate device.

Therefore, I cannot fulfill the request to describe acceptance criteria or a study based on the provided text, as this information is not present in the document.

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