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The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.

The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables in conjunction with various stimulation accessories, allow for tissue dilation and stimulation of peripheral nerve roots for location and identification during open and percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable includes a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip for connection to the stimulation accessories of this system. The stimulation accessories include general manual orthopedic surgical instruments previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers) and also include sterile/ single-use dilators which are subject of this submission. The subject dilators are a series of hollow tubes that fit over one another for the purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate instrument accessories, they are made from a conducting metal (Aluminum 6061-T6) with an insulated outer coating (Parylene C) to allow passage of current from a point on the proximal end where it connects to the Nerve Monitoring Cable to an un-insulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The subject dilators are offered sterile/single-use.

NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded. The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine. The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT Occipito-Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the system.