Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

K-Number: K220315 · 2022-03-11

Decision Date2022-03-11
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K220315. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty?

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Orthocon, Inc.. The 510(k) number is K220315.

When did MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty receive FDA 510(k) clearance?

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance on 2022-03-11, under 510(k) number K220315.

Who is the listed applicant for MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty?

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-XT Settable, Resorbable Hemostatic Bone Putty?

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

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.

View all 24 devices →

Related Devices (Code: MTJ)

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.

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.