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The intended use of the Normed Bi-Directional / Multi-Directional Jaw Distractor is identical to the description in the 510 (k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510 (k) number K952847. The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling 2 quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847

This document describes a 510(k) submission for an additional distributor of an already cleared device, the "Normed Bi-Directional / Multi-Directional Jaw Distractor." As such, it does not contain the typical information about acceptance criteria and a study to prove performance.

Instead, the submission states that:

• The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510(k) number K952847.
• The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling, quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847.

Therefore, the performance and acceptance criteria for this specific submission are satisfied by asserting that the device is identical to a previously cleared predicate device (K952847). The original 510(k) (K952847) would have contained the detailed studies and acceptance criteria to demonstrate safety and effectiveness.

Given the provided text, I cannot extract the information required in your request regarding acceptance criteria and studies, as this submission is for a new distributor of an existing device, not a new device requiring new performance studies. The core of this submission is the claim of "substantial equivalence" to a predicate device.

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