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The TENORTM Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross connectors, nuts, and screws made of medical grade titanium alloy. The TENOR™ Spinal System is used in conjunction with GDLH™ 5.5mm titanium alloy rods. Additionally, the TENOR™ Spinal System may be used with titanium alloy TSRH® hooks, TSRH® Low Profile CROSSLINK® plates, and MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or specific studies proving the device meets acceptance criteria.

The 510(k) process for devices like the TENOR™ Spinal System primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance metrics as might be seen for novel or high-risk devices.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies from the provided text.

Here's what I can infer from the document regarding the "proof" of the device:

• Substantial Equivalence: The primary "proof" mentioned is the claim of substantial equivalence (Section V) to the CD™ Horizon, TSRH®, and DYNA-LOK® Spinal Systems. This is a regulatory pathway, not a clinical study demonstrating performance against a specific set of acceptance criteria.
• Mechanical Testing: The document states, "Mechanical testing and other information were provided to demonstrate substantial equivalence." While mechanical testing is a type of study, the document does not elaborate on its details, such as specific tests performed, acceptance criteria for those tests, or the results.

To answer your questions, if this were a document that contained the requested information, it would typically appear in a "Performance Data," "Clinical Studies," or "Non-Clinical Studies" section, detailing the methodology, results, and comparison against pre-defined acceptance criteria. This information is absent in the provided 510(k) summary.

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