(105 days)
Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and tendon reattachment. It is intended for but not limited to hand surgery, orthopedic surgery, plastic surgery and podiatric surgery but is not intended for use in the spine.
Not Found
This document is an FDA 510(k) clearance letter for the BioPro Go-Ez Screw. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.