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510(k) Data Aggregation

    K Number
    K251433
    Device Name
    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
    Manufacturer
    Surgify Medical Oy
    Date Cleared
    2025-06-04

    (27 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgify Medical Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and General Surgical procedures.
    Device Description
    The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems. The Surgify Halo comprises: Shank, Locking Features, Burr Head, and Safety Mechanism (a self-centering ring and spring mechanism installed in the burr head). The moving ring, larger than the burr head, can adopt two positions: First Position (Hard Tissue Mode) where the ring protrudes, preventing cutting edges from engaging, and Second Position (Soft Tissue Mode) where the ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.
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    K Number
    K250380
    Device Name
    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
    Manufacturer
    Surgify Medical Oy
    Date Cleared
    2025-03-13

    (30 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgify Medical Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgify Halo is a sterile surgical burr indciated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures
    Device Description
    The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems. The Surgify Halo comprises: - Shank: Transfers rotary motion from the drill motor to the burr head. - Locking Features: Located at the distal end of the shank, these features securely attach the burr to the high-speed surgical drill. - Burr Head: Shaped with two cutting edges for cutting of bone and hard tissue. - Safety Mechanism: A self-centering ring and spring mechanism installed in the burr head. The moving ring, larger than the burr head, can adopt two positions: - First Position: (Hard Tissue Mode) The ring protrudes, preventing the cutting edges from engaging with the work material. - Second Position: (Soft Tissue Mode) The ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.
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    K Number
    K232684
    Device Name
    Surgify Halo
    Manufacturer
    Surgify Medical OY
    Date Cleared
    2023-11-29

    (89 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgify Medical OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.
    Device Description
    The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems. The Surgify Halo comprises: A shank, which transfers rotary movement of the drill motor to the head. Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill. A head that is shaped to have two cutting edges to cut bone and hard tissue. A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions: In the first position, the ring protrudes to a level higher than cutting edges and prevents the cutting edges from cutting into the work material. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material
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