MONTAGE XT Cranial Cement— 510(k) K253854

Substantially Equivalent

Orthocon, Inc.

FDA 510(k) clearance K253854 for MONTAGE XT Cranial Cement, Substantially Equivalent on 2026-01-02. Applicant: Orthocon, Inc..

Clearance details

Applicant: Orthocon, Inc.
Product code: Code GXP
Advisory panel: Neurology
Date received: 2025-12-03
Decision date: 2026-01-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Stamford, CT, US

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