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510(k) Data Aggregation

    K Number
    K250423

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-06

    (265 days)

    Product Code
    Regulation Number
    882.4460
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K191740, K941558, K193438, K163322

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI-compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

    The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required.

    The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems or navigation adaptors or other items.

    Device Description

    mb-FIX Cranial Stabilization Systems include three models of skull clamp:

    • Gold Standard Head Holding System
    • Premium Head Holding System
    • CT/MRI-compatible Head Holding System

    Each Head Holding System consists of a skull clamp and a base unit permitting attachment to an operating table.

    The device includes four skull pin models, each provided in two sizes, one for adults and one for children. The skull pins are manufactured of stainless steel, titanium, PEEK + stainless steel or PEEK + titanium. The skull pins containing stainless steel are MR Unsafe devices. The skull pins manufactured of titanium or of PEEK + titanium are MR Conditional devices.

    The CT/MRI-compatible Head Holding System is MR Safe and can be used in combination with the titanium or PEEK + titanium skull pins when intra-operative imaging is required. The Gold Standard and Premium Head Holding Systems are MR Unsafe.

    The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items.

    AI/ML Overview

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