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510(k) Data Aggregation

    K Number
    K132250
    Device Name
    INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
    Manufacturer
    INTEGRA LIFE SCIENCES CORPORATION
    Date Cleared
    2014-03-24

    (248 days)

    Product Code
    JWJ
    Regulation Number
    888.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA LIFE SCIENCES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.
    Device Description
    The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components: - Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) . - . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy - . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe) Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.
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    K Number
    K110528
    Device Name
    INTEGRA LED SURGICAL HEADLIGHT SYSTEM
    Manufacturer
    INTEGRA LIFE SCIENCES CORPORATION
    Date Cleared
    2011-05-11

    (76 days)

    Product Code
    FSR
    Regulation Number
    886.4335
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA LIFE SCIENCES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
    Device Description
    The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system. The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.
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    K Number
    K103248
    Device Name
    INTEGRITY SPINAL CARE SYSTEM
    Manufacturer
    INTEGRA LIFE SCIENCES
    Date Cleared
    2011-04-05

    (153 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA LIFE SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
    Device Description
    The Integrity Spinal Care System is a multi-function distraction table designed to apply distraction forces and controlled by a computer console. It has similar components for treatment and measurement, similar size, power source, and performance to the predicate devices. Key elements include a stand on/stand off tilt type bed, a split bed with two slideable cushions, a traction unit mounted to both ends of the bed with a belt pulley system attached to a vertical movable platform, a control panel for programming and controlling the traction unit, continuous monitoring of treatment parameters shown by LCD readout, automatic return to zero tension at the conclusion of treatment, an incorporated DVD player and headphones, and instantaneous release of tensions via a patient safety switch or stop buttons.
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