MONTAGE XT Cranial Cement
K-Number: K253854 · 2026-01-02
ApplicantOrthocon, Inc.
Decision Date2026-01-02
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
MONTAGE XT Cranial Cement is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2026-01-02 under approval number K253854. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MONTAGE XT Cranial Cement?
MONTAGE XT Cranial Cement is a medical device that received FDA 510(k) clearance on 2026-01-02. It is manufactured by Orthocon, Inc.. The 510(k) number is K253854.
When was MONTAGE XT Cranial Cement approved by the FDA?
MONTAGE XT Cranial Cement received FDA 510(k) clearance on 2026-01-02, under approval number K253854.
What company makes MONTAGE XT Cranial Cement?
MONTAGE XT Cranial Cement is manufactured by Orthocon, Inc..
What is the FDA product code for MONTAGE XT Cranial Cement?
The FDA product code for MONTAGE XT Cranial Cement is GXP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.