LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253447

    Validate with FDA (Live)

    Device Name
    Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2026-03-16

    (165 days)

    Product Code
    GXR
    Regulation Number
    882.5250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    18 - 120
    Reference & Predicate Devices
    K232771,K193052,K231270,K191140,K231903,K181539
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232771, K193052, K231270, K191140, K231903

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

    Orthocon Montage Flowable Settable, Resorbable Bone Paste is a self-setting cement indicated for fixation of bone flaps following craniotomy. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

    Device Description

    Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for fixation of bone flaps following craniotomy. The Montage Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the Montage Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE Flowable components must be mixed immediately prior to use.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1