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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) 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. The listed applicant is Orthocon, Inc.. The 510(k) number is K253447.

When did Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) receive FDA 510(k) clearance?

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

Who is the listed applicant for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

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 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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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.

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Related Devices (Code: GXR)

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.

K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.LK221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM Burr Hole Cover SystemSt Jude Medical

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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