K2M, Inc.

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Contact: John Kostuik, MD. - Chairman
Web: http://www.k2m.com
E-Mail:
Address: 751 Miller Dr. S.E., Suite F-1, Leesburg, Virginia 20175, USA
Phone: +1-(866)-526-4171 | Fax: +1-(703)-777-4338 | Map/Directions >>

Profile: K2M, Inc. specializes in products related to spinal disorders. Our product portfolio includes Mesa® spinal systems, Range® spinal systems, Denali® spinal systems, Serengeti® minimally invasive retractor systems, Pyrenees® cervical plate systems, and Aleutian® spacer systems. Our Mesa® spinal system is a top-loading, & low-profile spinal system featuring Zero-Torque Technology® and 60° range of motion, while providing the surgeon the ability to one-step lock without torsional stress applied to the spine. It offers controlled compression and distraction. Our Serengeti® minimally invasive retractor system features a screw-based method of retraction that provides a fixed position to the anatomy. Its design allows for one-step, percutaneous placement of the screw and retractor providing direct visualization & improved access for rod introduction.

FDA Registration Number: 3004774118

40 Products/Services (Click for related suppliers)

• Anterior Lumbar Plate System

• Awl (FDA Code: HWJ / 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.

• Bender (FDA Code: HXW / 888.4540)

• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)

• Bone Taps (FDA Code: HWX / 888.4540)

• Calipers (FDA Code: KTZ / 888.4150)

A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)

• Cervical Plate System

• Compression Instrument (FDA Code: HWN / 888.4540)

• Depth Gauge (FDA Code: HTJ / 888.4300)

A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Drill Bit (FDA Code: HTW / 888.4540)

• Drill Brace (FDA Code: HXY / 888.4540)

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• Fork (FDA Code: HXE / 888.4540)

• Hook, Screw and Rod Systems

• Invasive Retractor Systems

• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080)

• Medical Probes (FDA Code: HXB / 888.4540)

• Nail Extractors (FDA Code: HWB / 888.4540)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Pedicle Screw System

• Polyaxial Pedicular Screw System

• Probes (FDA Code: HXB / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

• Small Depth Gauge (FDA Code: HTJ / 888.4300)

• 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 Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)

• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)

• Tamps (FDA Code: HXG / 888.4540)

• Templates (FDA Code: HWT / 888.4800)

A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Thoracolumbar Lumbar Plate Systems

• Transverse Connectors

• Uni-Planar Screws

• Vertebral Body Replacement System

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wrench (FDA Code: HXC / 888.4540)