Profile: Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have developed a full line of vertically integrated products for spine surgeons. We manufacture and market a full line of spinal implants & surgical instruments. Our product portfolio and pipeline includes a variety of spinal disorder products & systems. Our DeltaLoc® Reveal anterior cervical plating system is an anterior plating solution, offering implants and instrumentation to help promote fusion & meet the surgeon's needs. Our anterior lumbar plate is a comprehensive set of implants and instruments providing anterior stabilization of the lumbar spine. Its low-profile design supports stabilization from L1 to S1,and features anatomically designed lumbar & sacral plates, one-step locking & a low-profile construct.

FDA Registration Number: 2027467

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• Anterior Cervical Plating System

• 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)

• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)

• Bone Fixation Nail (FDA Code: JDS / 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.

• Bone Fixation Plate (FDA Code: HRS / 888.3030)

• 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 Graft Substitutes

• 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 Screw Starter (FDA Code: HWD / 888.4540)

• Bone Taps (FDA Code: HWX / 888.4540)

• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• 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.

• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Cervical Interbody Systems

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

• Cervico Thoracic Fixation Systems

• Compression Instrument (FDA Code: HWN / 888.4540)

• Demineralized Bone Scaffolds

• Dense Corticocancellous Allografts

• 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.

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

• Drill Bit (FDA Code: HTW / 888.4540)

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

• Forceps (FDA Code: HTD / 878.4800)

• Fusion Posterior Metal/Polymer Spinal System (FDA Code: NQP / 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.

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

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

• Impactor (FDA Code: HWA / 888.4540)

• Intramedullary Fixation Rod and Accessories (FDA Code: HSB / 888.3020) An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

• Lumbar Fixation Systems

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

• Manual Osteotome (FDA Code: GFI / 878.4800)

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Minimally Invasive Surgery Systems

• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Orthopedic Knife (FDA Code: HTS / 888.4540)

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

• Pedicle Screws

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

• Posterior Fixation Systems

• Posterior Lumbar Retractors

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)