Profile: Ossur Americas specializes in providing orthopedic products and medical supplies. We provide braces & supports, casting & splinting, wound care products, podiatry supplies and surgical supplies. Our Airform night splint provides an effective treatment for plantar fasciitis, Achilles tendonitis, drop foot and post-static pain. Our universal wrist brace is used for carpal tunnel syndrome, mild sprains & strains to the wrist/hand, arthritis and post-cast healing. Our elastic knee support adds stability to the kneecap. It is made of long-life breathable elastic. It reduces swelling from minor injuries. It is available in small, medium, large and extra large sizes.

FDA Registration Number: 2020250

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• Lumbosacral Orthosis (FDA Code: IPY / 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.

• Mechanical External Limb Component Hand (FDA Code: IRA / 890.3420) An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

• Medical Insoles (FDA Code: KYS / 880.6280) A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.

• Needles

• Neoprene Ankle Sleeve

• Neoprene Elbow Sleeve

• Non-Invasive Traction Component (FDA Code: KQZ / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

• Occlusive Wound Dressing (FDA Code: NAD / 878.4020) An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Orthopedic Fixation Accessories (FDA Code: LYT / 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.

• Orthopedic Tape (FDA Code: HXT / 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.

• Padded Arm Sling

• Pediatric Foam Collar

• Protective Apparel

• Reusable Hot /Cold Pack (FDA Code: IME / 890.5700) A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.

• Rigid Cervical-Thoracic Orthosis (FDA Code: IQF / 890.3490)

• Shoulder Abduction Slings

• Shoulder Immobilizers

• Skin Pressure Protector (FDA Code: FMP / 880.6450) A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

• Skull Traction Tongs (FDA Code: HAX / 882.5960) Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

• Soft Rib Fracture Orthosis (FDA Code: IPX / 890.3490)

• Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Syringes

• Tennis Elbow Support with Pad & Strap

• Thoracic Orthosis, Brace (FDA Code: IPT / 890.3490)

• Traction Accessories (FDA Code: ILZ / 890.5925) A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.

• Traction Accessories, Leg Straps (FDA Code: ILZ / 890.5925)

• Ulnar Nerve Protector

• Universal Arm Sling

• Water Circulating Hot/Cold Pack (FDA Code: ILO / 890.5720) A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

• Wound Care

• Wraparound Knee Supports