Profile: Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the skull to the thoracic region. Our 3º anterior cervical plate system simplifies anterior cervical spinal fusion by addressing rigid, semi-rigid, and unconstrained options with a single system. Our Spinal-Stim delivers the success rates in bone growth stimulation for spine fusion and nonoperative salvage. In fact, 92% of patients receiving Spinal-Stim adjunctively have achieved fusion success.

The company has revenues of USD 10-25 Million, has ~20 employees and is CE certified.

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• Anterior Old Plating Systems

• Arthroscopes (FDA Code: HRX / 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)

• Bio Absorbable Plating Systems

• Bone Mallets (FDA Code: HXL / 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 Rasps (FDA Code: HTR / 878.4800)

• Bone Taps (FDA Code: HWX / 888.4540)

• Cervical Orthosis (FDA Code: IQK / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• Cervical Systems

• Drill Bit (FDA Code: HTW / 888.4540)

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

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

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

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Guiding Probes

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

• Impactor (FDA Code: HWA / 888.4540)

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Laminoplasty Fixation System

• Laparoscopic Probes

• Laser Power Probe

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

• Lumbosacral Fixation System

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Laminoplasty Plate Spine Orthosis (FDA Code: NQW / 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.

• Modular Spinal Fixation System

• Orbital Procedures, Titanium Plating Systems

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

• Orthopedic Spatula (FDA Code: HXR / 878.4800)

• Periodontal Probes

• Plating Systems

• Posterior

• Posterior Cervical Plating Systems

• posterior cruciate ligament Instruments

• Posterior Occipital Cervico -Thoracic System

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Screwdriver (FDA Code: HXX / 888.4540)

• Socket Pusher (FDA Code: HXO / 888.4540)

• Spinal Disc Shaving Equipment

• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 888.3050)

• 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.