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

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..

Clearance details

Applicant: Orthocon, Inc.
Product code: Code GXR
Advisory panel: Neurology
Date received: 2025-10-02
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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