Interventional Spine, Inc.

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Contact: Walter A. Cuevas - CEO
Web: http://www.i-spineinc.com
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Address: 13700 Alton Pkwy., Suite 160, Irvine, California 92618, USA
Phone: +1-(949)-472-0006, 800-497-0484 | Fax: +1-(949)-472-0016 | Map/Directions >>

Profile: Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of conservative treatment for chronic pain to complex open surgery for debilitating pain. Our PercuDyn™ is percutaneous bilateral facet-augmentation system for treating degenerative disc disease (DDD) and lumbar spinal stenosis (LSS). Our Perpos® PLS system is our percutaneous transfacet-pedicular compression system for posterior stabilization of lumbar spine fusion.

The company was founded in 2000.

24 Products/Services (Click for related suppliers)

• Bilateral Facet Augmentation Systems

• Bone Fixation Screw (FDA Code: HWC / 888.3040)

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Bone Taps (FDA Code: HWX / 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.

• Compression Instrument (FDA Code: HWN / 888.4540)

• Countersink (FDA Code: HWW / 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)

• Facet Screw Spinal Device System (FDA Code: MRW)

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

• Instrument Surgical Guide (FDA Code: FZX / 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.

• Nail Extractors (FDA Code: HWB / 888.4540)

• Nut Bolt Washer (FDA Code: HTN / 888.3030)

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

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

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Pedicular Compression Systems

• Percutaneous Biopsy Device (FDA Code: MJG / 878.4800)

• Screwdriver (FDA Code: HXX / 888.4540)

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

• 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.

• Surgical Hammer (FDA Code: FZY / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• Tissue Retractors

• Wire Cutters (FDA Code: HXZ / 888.4540)