Profile: Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we deliver laparoscopists with product quality. Our Stryker MIS joint replacement program encompasses multiple MIS surgical techniques, MIS friendly implants, specialized instrumentation, comprehensive on-line and hands-on training & support. Our Simplex P Bone Cement provides a unique formula coupled with proprietary manufacturing. We also offer a full line of Conquest Arthroscopic Manual Instruments including punches, scissors and graspers to perform any arthroscopic surgery procedure and accommodate individual surgeon preferences. Our Bone Plug Cutter uses a circular design to harvest the bone-to-bone autograft with circular bone blocks. Our image-based technology used in spinal surgery utilizes scans of the patient's anatomy and instruments that are tracked by the navigation System's camera.
• Surgical Cutter (FDA Code: FZT / 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. |
• Surgical helmet system (SHS) |
• Surgical Helmet Systems |
• Surgical Instrument Rack |
• Surgical Lamps (FDA Code: FTD / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. |
• Surgical Lavage Unit |
• Surgical Lights (FDA Code: FTD / 878.4580) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Surgical Suture Passers |
• Suture Passers |
• Synthetic Casting Materials |
• Synthetic Spacers |
• Syringe Infusion Pump |
• T-Type Infusion Blood Tubing Connector (FDA Code: FKB / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. |
• Tibial IM Nails |
• Tibial Inserts |
• Tilting Radiographic Table (FDA Code: IXR / 892.1980) A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered. |
• Titanium Cannulated Screws |
• Titanium Interference Screw |
• Titanium Plating Systems |
• Total Disc Replacements |
• Total Knee Systems |
• Total Shoulder Systems |
• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810) A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. |
• Traditional Bone Cements |
• Transfer Stretcher |
• Turning Frame |
• Ultrasonic Bone Cement Remover |
• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 888.3360) A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth. |
• Used Cast Saws |
• Used Cystoscopes |
• Used Infusion Pumps |
• Uterine Resectoscopes |
• vacuum Bone Cement Mixing Systems |
• Vacuum Collection Bottle (FDA Code: KDQ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Video Arthroscopes |
• Volumetric Infusion Pumps |
• Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX / 880.6740) |
• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump. |
• Water Resistant Casting Material |
• Wheeled (Mobile) Stretcher (FDA Code: FPO / 880.6910) A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance. |
• Wide Angle Arthroscopes |
• Wire Cutters (FDA Code: HXZ / 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. |
• Wire Driver |
• Wrist Implants, Wrist Fracture Hardware |
• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements. |