Arthrex, Inc.


Web: http://www.arthrex.com
Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
Phone: +1-(800)-933-7001 | Fax: +1-(239)-598-5534 | Map/Directions >>
 
 

Profile: Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develop surgical solutions for arthroscopic and minimally invasive orthopaedic surgical procedures. We also offer knee arthroscopy, shoulder arthroscopy, hip arthroscopy, foot & ankle, and hand & wrist courses.

FDA Registration Number: 1220246

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• Absorbable Corkscrew Suture Anchor
• Absorbable Staple (FDA Code: MNU / 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.
• Absorbable Suture Anchors
• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)
• Adhesive Bandage Strip
• Adhesive Bandages (FDA Code: KGX / 880.5240)
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
• Adult-Pediatric Volumetric Infusion Pumps
• Ambulatory Infusion Pumps
• Anesthesia Infusion Pump Tubing
• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725)
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
• 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.
• Arthroscopic Accessories (FDA Code: NBH / 888.1100)
• Arthroscopy Instruments
• Autoclavable Arthroscopes
• Autoclavable Small Joint Arthroscopes
• Batteries & Battery Assemblies for Infusion Pumps
• Bio Absorbable Suture Anchors
• Blood Bank Supplies (FDA Code: KSS / 864.9050)
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
• 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 Fixation Staple (FDA Code: JDR / 888.3030)
• Bone Staple Driver (FDA Code: HXJ / 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.
• 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.
• Cannulated Drill Bit
• Cannulated Interference Screws
• Cerclage Applier (FDA Code: HXN / 888.4540)
• Collagen Wound Dressing (FDA Code: KGN)
• Constant-flow Infusion Pump
• 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 Suture Retrievers
• Drill Bit (FDA Code: HTW / 888.4540)
• Drill Bits & Bone Taps
• Drug Wound Dressing (FDA Code: FRO)
• Dual-Channel Volumetric Infusion Pump
• Elastic Adhesive Bandages
• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
• Endoscopic Camera without Audio (FDA Code: FWL / 878.4160)
A surgical camera and accessories is a device intended to be used to record operative procedures.
• Endoscopic Carpal Tunnel Release Systems
• Enteral Irrigation Kit w/Piston Syringe
• Fiberoptic Surgical Light (FDA Code: FST / 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.
• Finger Cot (FDA Code: LZB / 880.6250)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Finger Cot Bandages
• Fixation Cerclage (FDA Code: JDQ / 888.3010)
A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
• Fixed Arthroscopes
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)
• Flexible Fabric Adhesive Bandages
• Fluid Management Systems
• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)

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