Spinal Elements, Inc.

Contact: Todd Andres - President & CEO
Address: 2744 Loker Ave. W. Suite 100, Carlsbad, California 92010, USA
Phone: +1-(760)-607-0121 | Fax: +1-(760)-607-0125 | Map/Directions >>

Profile: Spinal Elements, Inc. deals with orthopedic products. We specialize in motion preservation and spinal fusion. Our Mosaic™ cervical implant system has a radiolucent material design that improves radiographic visualization of the fusion mass. Its stackable design allows for multilevel fusion through a small transverse incision and limited exposure, one-level at a time. This avoids the need to open the entire surgical site at any one time. Our Lucent® implants are curved and straight implants that are MRI compatible. They have large interior graft volume and optimized bony integration. Their one way directional ridges prevent implant migration.

FDA Registration Number: 3004893332

26 Products/Services (Click for related suppliers)  
• Anterior Cervical Plate Systems
• Anterior Lumbar Cage Systems
• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300)
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.
• Cervical Cage Systems
• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)
• Fiberoptic Surgical Light (FDA Code: FST / 878.4580)
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
• Fixation Pins
• Lamina Spreader
• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080)
• Mallets
• Myringotomy Tube Inserter (FDA Code: JYM / 874.4420)
• Nerve Retractor
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
• Osteotomes
• Pedicle Screw System
• Posterior Lumbar Cage Systems
• Rasps
• Rongeurs
• Spinal Implant Removal System
• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 888.3050)
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060)
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.
• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070)
Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.
• Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070)
• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)
• Tamps (FDA Code: HXG / 888.4540)

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