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FDA 510(k)

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

K-Number: K253447 · 2026-03-16

ApplicantOrthocon, Inc.
Decision Date2026-03-16
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-16 under approval number K253447. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Orthocon, Inc.. The 510(k) number is K253447.

When was Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) approved by the FDA?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) received FDA 510(k) clearance on 2026-03-16, under approval number K253447.

What company makes Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is manufactured by Orthocon, Inc..

What is the FDA product code for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

The FDA product code for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is GXR.

Related Clinical Trials

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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.

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