Paradigm Spine, Llc

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Contact: Marc Viscogliosi
Web: http://www.paradigmspine.com
E-Mail:
Address: 505 Park Ave, 14th Floor, New York, New York 10022, USA
Phone: +1-(212)-583-9700 | Fax: +1-(646)-349-1173 | Map/Directions >>

Profile: Paradigm Spine, Llc is a provider of non-fusion spinal implant solutions. We offer Coflex™, an implant used in the treatment of facet arthrosis and de-compressive procedures. Our products are used for spinal stabilization and help re-balance the spinal segment & restore natural anatomical function. Our DCI™ implant provides stable and controlled motion, which allows the spine to be functionally dynamic. After insertion, the implant works as a shock absorber to prevent accelerated degeneration in the segments. Our coflex-F™ implant is a minimally invasive lumbar fusion device that provides significant segmental stability. Our DSS™ contains spring stiffness, that reduces the range of motion in the lumbar spine.

FDA Registration Number: 3005725110

20 Products/Services (Click for related suppliers)

• 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.

• 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.

• Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP / 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.

• Interspinous Implants

• Medical Probes (FDA Code: HXB / 888.4540)

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

• Probes (FDA Code: HXB / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

• Socket Pusher (FDA Code: HXO / 888.4540)

• 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 Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070)

• Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070)

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

• Surgical Retractor (FDA Code: GAD / 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.

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Wrench (FDA Code: HXC / 888.4540)