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FDA 510(k)

MONTAGE Settable, Resorbable Hemostatic Bone Putty

K-Number: K213418 · 2023-08-30

ApplicantOrthocon, Inc.
Decision Date2023-08-30
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

MONTAGE Settable, Resorbable Hemostatic Bone Putty is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2023-08-30 under approval number K213418. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTAGE Settable, Resorbable Hemostatic Bone Putty?

MONTAGE Settable, Resorbable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Orthocon, Inc.. The 510(k) number is K213418.

When was MONTAGE Settable, Resorbable Hemostatic Bone Putty approved by the FDA?

MONTAGE Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance on 2023-08-30, under approval number K213418.

What company makes MONTAGE Settable, Resorbable Hemostatic Bone Putty?

MONTAGE Settable, Resorbable Hemostatic Bone Putty is manufactured by Orthocon, Inc..

What is the FDA product code for MONTAGE Settable, Resorbable Hemostatic Bone Putty?

The FDA product code for MONTAGE Settable, Resorbable Hemostatic Bone Putty 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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