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The GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

** Warning: GSO Bone Fixation Devices are not indicated for spinal fixation. **

The GSO Bone Fixation Fasteners consist of sterile and non-sterile, single-use, smooth and threaded Kirschner wires and Steinmann pins (ranging in length from 4 to 12 inches and in diameter from 0.028 to 0.177 inches), and cortical, cancellous, and malleolar bone screws (ranging in length from 6 to 160 mm and in screw diameter from 1.5 to 6.5mm). All GSO Bone Fixation Fasteners are manufactured from 316-LVM stainless steel conforming to standard ASTM-F138.

The provided text is a 510(k) summary for a medical device (GSO Bone Fixation Fasteners) and does not describe any acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously marketed predicate devices.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states:

• Non-Clinical Testing: "Non-clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates."
• Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between the GSO Bone Fixation Fasteners and the predicates."

This means no studies were conducted by the applicant for this 510(k) submission to establish device performance against specific acceptance criteria. Substantial equivalence was based on similarities in intended use, design, indications for use, and material to existing devices.

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