Search Results

The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

The provided text is a 510(k) summary for the Zavation Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, or any study results for performance validation.

The document explicitly states: "Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device." This indicates that the current submission (K181244) is not based on new performance testing but rather on the equivalence of sterilized versions of a previously cleared device.

Therefore, I cannot provide the requested information. The document is missing:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, number of experts, and adjudication methods.
3. Information on multi-reader, multi-case comparative effectiveness studies.
4. Information on standalone algorithm performance.
5. Details on the type of ground truth used or how it was established.
6. Sample size for a training set.

The document is primarily a regulatory filing asserting substantial equivalence based on technological characteristics and intended use being the same as predicate devices (K112533 and K130030), with the current 510(k) specifically addressing the addition of sterile packaged options.

Ask a specific question about this device