Centinel Spine, Inc.

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Contact: James May
Web: http://www.centinelspine.com
E-Mail:
Address: 505 Park Avenue, 14th Floor, Franklin D Roosevelt, New York 10022, USA
Phone: +1-(952)-885-0500 | Fax: +1-(952)-885-0200 | Map/Directions >>

Profile: Centinel Spine, Inc. provides surgical equipment. We offer Stalif TT™ and Stalif C&trade products. The Stalif TT™ is designed for use with any of the standard anterior approaches to the anterior/antero-lateral spine, such as abdominal transperitoneal approaches in the mid line or lateral to the mid line. The Stalif TT&trade intervertebral body fusion system is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

FDA Registration Number: 3007494564

16 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.

• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)

• Drill Bit (FDA Code: HTW / 888.4540)

• Impactor (FDA Code: HWA / 888.4540)

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

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

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

• 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 Products

• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)

• Surgical Equipment

• Surgical Instrument Tray (FDA Code: FSM / 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.

• 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.