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FDA 510(k)

MONTAGE-QS Settable, Resorbable Hemostatic Bone

K-Number: K191140 · 2019-07-18

ApplicantOrthocon, Inc.
Decision Date2019-07-18
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

MONTAGE-QS Settable, Resorbable Hemostatic Bone is a medical device manufactured by Orthocon, Inc.. It received FDA 510(k) clearance on 2019-07-18 under approval number K191140. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTAGE-QS Settable, Resorbable Hemostatic Bone?

MONTAGE-QS Settable, Resorbable Hemostatic Bone is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Orthocon, Inc.. The 510(k) number is K191140.

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

MONTAGE-QS Settable, Resorbable Hemostatic Bone received FDA 510(k) clearance on 2019-07-18, under approval number K191140.

What company makes MONTAGE-QS Settable, Resorbable Hemostatic Bone?

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

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

The FDA product code for MONTAGE-QS Settable, Resorbable Hemostatic Bone is MTJ.

Other Devices by Orthocon, Inc.

K153317HEMASORBPLUS Resorbable Hemostatic Bone Putty K193052HBP6 Settable, Resorbable Hemostatic Bone Paste K202363HBP7 Settable Hemostatic Bone Putty K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K231475MONTAGE-QS Settable, Resorbable Bone Putty K232998Montage- XT Settable, Resorbable Hemostatic Bone Putty

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Related Devices (Code: MTJ)

K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc. K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc. K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. K232998Montage- 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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