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510(k) Data Aggregation

    K Number
    K253732

    Validate with FDA (Live)

    Device Name
    Permatage Flowable, Settable Bone Paste
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2026-03-13

    (109 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Type
    Traditional
    Panel
    Neurology
    Age Range
    18 - 150
    Reference & Predicate Devices
    K202363,K241027
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Orthocon Permatage Flowable, Settable Bone Paste is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Flowable, Settable Bone Paste should be used only in skeletally mature individuals.

    Device Description

    Permatage Flowable, Settable Bone Paste is a sterile, biocompatible, nonabsorbable material of Paste-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of paste-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, paste-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

    AI/ML Overview

    N/A

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