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510(k) Data Aggregation

    K Number
    K252662
    Device Name
    UniBur
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2025-09-19

    (28 days)

    Product Code
    HBE,ERL,HWE
    Regulation Number
    882.4310
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K183515,K202120
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UniBur is for single use only. This device is designed to be used with electric surgical instruments manufactured by Nakanishi INC. This device is intended for: cutting, drilling, removal, and shaping of bones in the fields of Neuro, Spine and ENT surgery.

    Device Description

    The UniBur is a single-use, sterile medical device designed for cutting, drilling, removal, and shaping of bones, used with the Primado2 Total Surgical System (K132264) and used in the fields of neuro, spine, and ENT surgery.

    The UniBur is designed to be connected to the slim motor handpiece of the Primado2 Total Surgical System.

    The UniBur has 22 types of product variations based on differences in the length (3 types) and bending angle of the bur guard (3 types), the diameter of the bur for bone cutting (from φ0.6 mm to φ4.5 mm), and the grit size of the diamond embedded in the bur.

    The UniBur consists of Diamond, Nickel, Stainless steel, Phosphor bronze, Stainless steel, FKM, Polyamide and PTFE.

    AI/ML Overview

    N/A

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