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FDA 510(k)

Montage Flowable Settable, Resorbable Bone Paste

K-Number: K232771 · 2024-02-16

ApplicantOrthocon, Inc.
Decision Date2024-02-16
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Montage Flowable Settable, Resorbable Bone Paste is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2024-02-16 under approval number K232771. 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 Flowable Settable, Resorbable Bone Paste?

Montage Flowable Settable, Resorbable Bone Paste is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Orthocon, Inc.. The 510(k) number is K232771.

When was Montage Flowable Settable, Resorbable Bone Paste approved by the FDA?

Montage Flowable Settable, Resorbable Bone Paste received FDA 510(k) clearance on 2024-02-16, under approval number K232771.

What company makes Montage Flowable Settable, Resorbable Bone Paste?

Montage Flowable Settable, Resorbable Bone Paste is manufactured by Orthocon, Inc..

What is the FDA product code for Montage Flowable Settable, Resorbable Bone Paste?

The FDA product code for Montage Flowable Settable, Resorbable Bone Paste is GXP.

Other Devices by Orthocon, Inc.

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Related Devices (Code: 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.

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