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Montage Flowable Settable, Resorbable Bone Paste

by Orthocon, Inc. 2 variants

510(k) K232771

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232771 Date16 Feb 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXP
Device Class
Class II
Regulation
21 CFR Part 882.5300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Montage Flowable Settable, Resorbable Bone Paste is a methyl methacrylate-based device used as a self-setting cement. It is indicated for the fixation of bone flaps following craniotomy procedures.

This device has received FDA 510(k) clearance. It is supplied for surgical use and is categorized under the neurology medical specialty.

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See all devices from Orthocon, Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use for Montage Flowable Bone Paste?

    This device is indicated for the fixation of bone flaps following craniotomy procedures. It functions as a self-setting, resorbable cement to secure bone segments in place during the surgical recovery process.

  • What is the chemical composition of this bone paste?

    Montage Flowable Settable, Resorbable Bone Paste is a methyl methacrylate-based device. This formulation allows it to act as a self-setting cement suitable for neurological surgical applications.

  • Has this device received regulatory authorization?

    Yes, Montage Flowable Settable, Resorbable Bone Paste has received FDA 510(k) clearance. It is categorized under the neurology medical specialty and is identified by K-number K232771.