Custom Spine, Inc.

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Contact: Mahmoud Abdelgany
Web: http://www.customspine.com
E-Mail:
Address: 1140 Parsippany Blvd., Suite 201, Parsippany, New Jersey 07054, USA
Phone: +1-(973)-808-0019 | Fax: +1-(973)-808-0707 | Map/Directions >>

Profile: Custom Spine, Inc. develops spinal implants and instrumentations. We focus on the cause of chronic pain in the cervical region which includes cervical disc herniations and stenosis as well as spondylosis of the cervical spine. We develop Regent ACP for the treatment of patients suffering from degenerative disease of the cervical spine. It is a versatile anterior cervical plate system that was designed to provide the surgeon with flexibility in treatment options as well as instill confidence that the construct is fully locked and secure. We offer thoracolumbar spine treatments with the polyaxial pedicle screw system has a spinal fixation system which includes a monoaxial system. This has polyaxial cross connectors as well as a variety of interbody devices. 0ur monoaxial screw system is used for the treatment of thoracolumbar deformity, tumor and trauma through an antero-lateral or posterior approach. Our pathway posterior & transforaminal lumbar interbody fusion devices are designed as a replacement implant for degenerative, damaged, unstable or collapsed discs.

35 Products/Services (Click for related suppliers)

• Anterior Cervical Plate

• 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)

• Bone Rasps (FDA Code: HTR / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Bone Staple Driver (FDA Code: HXJ / 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.

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

• Forceps (FDA Code: HTD / 878.4800)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

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

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

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

• Probes (FDA Code: HXB / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

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

• Spinal Implants

• 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)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• 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.

• Wrench (FDA Code: HXC / 888.4540)