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FDA 510(k)

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

K-Number: K231386 · 2023-07-11

ApplicantOrthocon, Inc.
Decision Date2023-07-11
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2023-07-11 under approval number K231386. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a medical device that received FDA 510(k) clearance on 2023-07-11. It is manufactured by Orthocon, Inc.. The 510(k) number is K231386.

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

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste received FDA 510(k) clearance on 2023-07-11, under approval number K231386.

What company makes Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

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

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

The FDA product code for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is MTJ.

Other Devices by Orthocon, Inc.

K153317HEMASORBPLUS Resorbable Hemostatic Bone Putty K191140MONTAGE-QS Settable, Resorbable Hemostatic Bone K193052HBP6 Settable, Resorbable Hemostatic Bone Paste K202363HBP7 Settable Hemostatic Bone Putty K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K231475MONTAGE-QS Settable, Resorbable Bone Putty

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Related Devices (Code: MTJ)

K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc. K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc. K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. K220315MONTAGE-XT Settable, Resorbable Hemostatic 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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