Spine Wave, Inc.

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Web: http://www.spinewave.com
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Address: Three Enterprise Drive, Suite 210, Shelton, Connecticut 06484, USA
Phone: +1-(203)-944-9494, 877-844-4225 | Fax: +1-(203)-944-9493 | Map/Directions >>

Profile: Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, and NuCore®. Our product portfolio includes the StaXx® XD expandable device, the CapSure® PS2 spine system, the StaXx® FX structural kyphoplasty system, and the NuCore® injectable nucleus. The StaXx® XD expandable device is an expandable polyetheretherketone (PEEK) spacer that allows for controlled in situ distraction in 1 mm increments. Its low-profile, expandable design allows for a significantly smaller working channel compared to a standard monolithic implant, which may result in less bone removal and nerve retraction. It is designed to be expanded in situ to allow surgeons to more precisely restore proper biomechanics and balance, while accurately matching the patient's anatomy. The CapSure® PS2 spine system is a top loading pedicle screw system designed to treat degeneration, tumor, or trauma of the thoracolumbar spine. It features a unique screw design that allows for its maximum polyaxial angulation even when the screw is fully seated into the pedicle.

FDA Registration Number: 3004638600

36 Products/Services (Click for related suppliers)

• Arthroscopic Accessories (FDA Code: NBH / 888.1100)

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

• 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 Taps (FDA Code: HWX / 888.4540)

• Cement Dispenser (FDA Code: KIH / 888.4200)

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Curettes (FDA Code: HTF / 878.4800)

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Forceps (FDA Code: HTD / 878.4800)

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

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

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

• Impactor (FDA Code: HWA / 888.4540)

• Manual Osteotome (FDA Code: GFI / 878.4800)

• Medical Devices

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Nail Extractors (FDA Code: HWB / 888.4540)

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

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

• Pedicle Screw System

• Probes (FDA Code: HXB / 888.4540)

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

• 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)

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.

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

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

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• 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.

• Vertebral Body Replacement System

• Vertebroplasty Polymeric Modular Pre-Formed Bone Cement (FDA Code: OBL / 888.3027)

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

• Wrench (FDA Code: HXC / 888.4540)