Spinefrontier, Inc.

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Contact: John Sullivan
Web: http://www.spinefrontier.com
E-Mail:
Address: 500 Cummings Center, Suite 3500, Beverly, Massachusetts 01915, USA
Phone: +1-(978)-2323990 | Fax: +1-(978)-2323991 | Map/Directions >>

Profile: Spinefrontier, Inc. provides services for operative instruments, medical devices, diagnostic equipments and rehabilitation aids used in the treatment of spinal diseases. We produce devices and instruments for spinal fusion & less exposure surgery. Our less exposure surgery minimizes tissue destruction that allows less exposure surgery in contrast to developing technologies to limit incision size. Our Chameleon™ facetfuse MIS screw system enables fusion of the facet joints, providing posterior surgical treatment of a variety of spine disorders.

FDA Registration Number: 3005977257

14 Products/Services (Click for related suppliers)

• Bone Trephine (FDA Code: HWK / 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.

• Diagnostic Equipment

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

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

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

• Instrument for Spine Surgery

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

• Orthopedic Burr (FDA Code: HTT / 888.4540)

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

• Rehabilitation Aids

• Screwdriver (FDA Code: HXX / 888.4540)

• 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.

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