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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK® Spinal System is indicated for skeletally mature 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK® Spinal 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the DYNA-LOK® Spinal 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The DYNA-LOK® Spinal System consists of plates, bolts, screws, hooks, CROSSLINK® Plates and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the DYNA-LOK® Spinal System is to provide stabilization during the development of a solid spinal fusion.

The DYNA-LOK® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The DYNA-LOK® Spinal System implant Components may be sold either sterile or non-sterile

This document is a 510(k) summary for the DYNA-LOK® Spinal System, a medical device. It describes the device, its indications for use, and its substantial equivalence to a predicate device.

There is no information in the provided text regarding acceptance criteria, device performance studies, or details about data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a regulatory submission for premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific performance studies with acceptance criteria in the manner of an AI/software as a medical device (SaMD) submission.

Therefore, I cannot provide the requested table and detailed study information based on the given input. The content is about the device's description, indications for use, and a regulatory approval letter.

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