Profile: EBI Patient Care, Inc. provides braces thermal therapy devices, spinal endoscopic system and cast bandage.

FDA Registration Number: 3003435252

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• Abdominal Binders (FDA Code: FSD / 880.5160)

• Anesthetic Conduction Catheter (FDA Code: BSO / 868.5120) An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

• Arm Slings (FDA Code: ILI / 890.3640) An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

• 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)

• 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)

• Bone Fixation Plate (FDA Code: HRS / 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 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 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.

• Cast Bandage (FDA Code: ITG / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Cast Component (FDA Code: LGF / 888.5940) A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

• Cast Shoe (FDA Code: IPG / 890.3025)

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

• 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.

• Clavicle Splint (FDA Code: IQJ / 890.3490)

• Compression Instrument (FDA Code: HWN / 888.4540)

• Countersink (FDA Code: HWW / 888.4540)

• 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 Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Drill Bit (FDA Code: HTW / 888.4540)

• External Ankle Brace (FDA Code: ITW / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• External Brace Knee Joint (FDA Code: ITQ / 890.3475)

• 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.

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

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

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

• Hand Splint and Component (FDA Code: ILH / 890.3475)

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

• Impactor (FDA Code: HWA / 888.4540)

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

• 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.

• Invasive Bone Growth Stimulator (FDA Code: LOE)

• Limb Brace Orthosis (FDA Code: IQI / 890.3475)

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

• Lumbosacral Orthosis (FDA Code: IPY / 890.3490)

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metallic Bone Fixation Nail (FDA Code: NDH / 888.3030)

• Metallic Non-Spinal Bone Fixation Plate (FDA Code: NDF / 888.3030)

• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

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

• Nail Extractors (FDA Code: HWB / 888.4540)

• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 888.3030)

• Non-Invasive Bone Growth Stimulator (FDA Code: LOF)