(90 days)
The Leibinger Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
The Leibinger Quik Disk Titanium Clamp System consists of a two-piece titanium implant and associated nonpowered neurosurgical instruments. The system allows for timely fixation of cranial flaps to the surrounding cranium after craniotomies in lieu of bone plate and screw methods. The Quik Disk has two parallel 15 mm diameter titanium disks that are connected by an internal, serrated breakaway stem and grasping clamp assembly that is fully contained between the two discs.
This 510(k) summary describes a medical device, the Leibinger Quik Disk Titanium Clamp System, which is a titanium implant intended for fixing cranial flaps after craniotomies. The provided text does not include any information about acceptance criteria, device performance, or any studies conducted.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies. The document only describes the device, its intended use, and states its substantial equivalence to other legally marketed devices.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).