(202 days)
Citieffe Rondò Cannulated Screw is intended for fracture fixation of small and long bones and pelvis. The system is not intended for spinal use.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Citieffe Rondò Cannulated Screw (Pin)". This type of document declares substantial equivalence to a predicate device and permits marketing, but it does not contain the details of acceptance criteria or the specific study results that would be found in a more technical submission or scientific publication.
Therefore,Based on the provided text, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria. The text is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use, allowing it to be marketed. It does not elaborate on the specific performance metrics, study designs, or analytical results that led to this determination.
§ 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.