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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2026-01-02 under 510(k) 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. The listed applicant is Orthocon, Inc.. The 510(k) number is K253854.

When did MONTAGE XT Cranial Cement receive FDA 510(k) clearance?

MONTAGE XT Cranial Cement received FDA 510(k) clearance on 2026-01-02, under 510(k) number K253854.

Who is the listed applicant for MONTAGE XT Cranial Cement?

The FDA 510(k) record lists Orthocon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONTAGE XT Cranial Cement?

The FDA product code for MONTAGE XT Cranial Cement is GXP.

Other records listing Orthocon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261265Permatage XT Settable Bone PuttyK261439Permatage Flowable, Settable Hemostatic Bone PasteK253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)K253732Permatage Flowable, Settable Bone PasteK243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyK243506Montage-XT Settable Bone Putty

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Related Devices (Code: GXP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.

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.

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