(82 days)
The NuVasive® Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The NuVasive® Cement Restrictor is an implantable PEEK device indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
The device is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The hollow core is used to hold bone cement.
The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) summary for the NuVasive® Cement Restrictor, a medical device. As such, it does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove safety and effectiveness through new clinical studies. The document explicitly states:
- "G. Summary of Non-Clinical Tests (Not Applicable)."
- "H. Summary of Clinical Tests (Not Applicable)."
Therefore, I cannot provide the requested information from the provided text. The document indicates that safety and effectiveness are established through comparison to predicate devices, rather than through independent studies with acceptance criteria.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.