Profile: Orfit Industries America develops and produces thermoplastic materials for immobilization & fixation purposes in medical applications. We are accredited with ISO 9001:2000 certification.

The company has ~30 employees and is ISO 9001, ISO 9002, CE certified.

FDA Registration Number: 3005518451

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• Ankle & Foot Orthoses

• Arm & Shoulder Orthoses

• Brace Setting Twister (FDA Code: ITO / 890.3410) An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

• Braces & Orthoses

• Cast

• 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.

• Casting Materials

• Casting Materials and Equipment, Casting Stands

• Casting Padding Kits

• Computed Tomography

• Computed Tomography Accessories

• Contract Manufacturers

• External Brace Component Stirrup (FDA Code: ITC / 890.3410)

• External Limb Component, Ankle/Foot (FDA Code: ISH / 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.

• External Non-Inflatable Extremity Splint (FDA Code: FYH / 878.3910) A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• Finger & Thumb Orthoses

• FMRI (Functional Magnetic Resonance Imaging) Accessories

• Hand & Wrist Orthoses

• Hand Braces & Orthotics

• Hand Splint and Component (FDA Code: ILH / 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.

• Healing Environments & Visual Therapy Aids

• Hip Orthoses

• IGRT (Image-guided Radiation Therapy) Device

• Image-guided Radiation Therapy Accessories

• Image-guided Surgery Accessories

• IMRT (Intensity Modulated Radiation Therapy) Devices

• Intensity Modulated Radiation Therapy Accessories

• Knee Orthoses

• Limb & Truncal Orthosis (FDA Code: MRI / 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.

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

• Linear Accelerator Accessories

• Linear Accelerators

• Lower Extremity Prostheses Components

• Lumbar Orthosis, Brace (FDA Code: IQE / 890.3490)

• Medical Linear Accelerator (FDA Code: IYE / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• MRI (Magnetic Resonance Imaging) Accessories

• Oncology Radiation Systems

• Orthopedics Instruments

• Pediatric Hip Orthoses

• PET (Positron Emission Tomography) Accessories

• Physical Therapy Aids

• Positioning System Accessories

• Post-Operative Hip Orthoses

• Radiation Oncology Device Accessories

• Radiation Oncology Kits

• Radiation Therapy Accessories

• Radiation Therapy Devices

• Radiation Therapy Equipment Service

• Radiation Therapy Installation Service

• Radiation Therapy Kits