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510(k) Data Aggregation

    K Number
    K150166
    Device Name
    Extremity Medical Suture Anchor
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2015-02-23

    (28 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
    Device Description
    The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.
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    K Number
    K143402
    Device Name
    Extremity Medical Calcaneal Osteotomy Device
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2015-02-04

    (68 days)

    Product Code
    HWC, HRS
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
    Device Description
    The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
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    K Number
    K121349
    Device Name
    IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2012-07-18

    (75 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
    Device Description
    The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.
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    K Number
    K121417
    Device Name
    XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2012-07-18

    (68 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
    Device Description
    The EXTREMITY MEDICAL Screw System
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    K Number
    K101700
    Device Name
    IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2010-10-12

    (117 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
    Device Description
    The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.
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    K Number
    K093770
    Device Name
    EXTREMITY MEDICAL SCREW SYSTEM
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2010-04-28

    (141 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
    Device Description
    The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.
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    K Number
    K092548
    Device Name
    EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2009-12-15

    (118 days)

    Product Code
    KYI
    Regulation Number
    888.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with: - Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb) - Decreased motion, pinch, and grip strength - X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination. - Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
    Device Description
    The EXTREMITY MEDICAL Trapezium Prosthesis
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    K Number
    K091577
    Device Name
    EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2009-07-24

    (52 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
    Device Description
    The EXTREMITY MEDICAL Midfoot Screw System
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    K Number
    K082934
    Device Name
    EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2009-04-23

    (204 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
    Device Description
    The EXTREMITY MEDICAL Midfoot Screw System
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    K Number
    K083151
    Device Name
    EXTREMITY MEDICAL SUTURE ANCHOR
    Manufacturer
    EXTREMITY MEDICAL LLC
    Date Cleared
    2009-01-22

    (90 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXTREMITY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction
    Device Description
    The EXTREMITY MEDICAL Suture Anchor
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