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510(k) Data Aggregation

    K Number
    K160304
    Device Name
    OsteoBullet Compression Screw
    Manufacturer
    Phalanx Innovations
    Date Cleared
    2016-04-29

    (85 days)

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

    Phalanx Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.
    Device Description
    The OsteoBullet Compression Screw has a wide range of diameters and lengths for use in a variety of fracture treatments. Implants are available as cannulated or non-cannulated and made from Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants are provided sterile and are for single use only. The system includes instrumentation to aid in delivery of the implants including drill guides, guide wires, depth gauge, manual drills, manual stop drills, taps, and drivers.
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    K Number
    K160194
    Device Name
    StarFuse Interphalangeal Pin
    Manufacturer
    Phalanx Innovations
    Date Cleared
    2016-04-26

    (90 days)

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

    Phalanx Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.
    Device Description
    The StarFuse Interphalangeal Pin is a fusion device available in a range of profile diameters and lengths as well as straight or pre-bent options. Implants are made from 316LVM Stainless Steel per ASTM F138 and range in size from 3 to 4 mm in diameter and 16 to 30 mm in length.
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