(21 days)
Internal fixation devices to aid the surgeon in the stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up to 7mm. The head may be center drive or cross drive. The screw is designed so that a predrilled hole is not required, but may be used. Five screws are placed within a disposable cartridge A disposable screwdriver blade is loaded between each screw. The cartridges are delivered to the user sterile. The cartridge is loaded into a driver blade system for delivery to the patient.
The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Rapidfire Self Drilling Screws), primarily detailing its intended use, description, potential risks, and the FDA's substantial equivalence determination.
Therefore, I cannot provide the requested information.
§ 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.