Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)— 510(k) K253447

Name: FDA 510(k) clearance K253447
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

Orthocon, Inc.

FDA 510(k) clearance K253447 for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover), Substantially Equivalent on 2026-03-16. Applicant: Orthocon, Inc.. Device class: 2.

Summary

Orthocon's Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is filed under GXR, burr hole covers. The record doesn't describe the product beyond its name and that code name.

Class II, 21 CFR 882.5250. Neurology is both the classification panel and the review panel. It was a Traditional 510(k).

Orthocon filed from Stamford, Connecticut. The decision came 165 calendar days after receipt (October 2, 2025 to March 16, 2026).

Clearance details

Applicant: Orthocon, Inc.
Product code: Product code GXR
Device class: Class 2
Regulation: 21 CFR 882.5250
Advisory panel: Neurology
Date received: 2025-10-02
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

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K253732 — Permatage Flowable, Settable Bone Paste2026-03-13
K253854 — MONTAGE XT Cranial Cement2026-01-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.