NovoSorb® MTX
K-Number: K242149 · 2025-03-05
ApplicantPolynovo Biomaterials Pty, Ltd.
Decision Date2025-03-05
Product CodeQSZ
DecisionSubstantially Equivalent
Device Summary
NovoSorb® MTX is a medical device manufactured by Polynovo Biomaterials Pty, Ltd.. It received FDA 510(k) clearance on 2025-03-05 under approval number K242149. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovoSorb® MTX?
NovoSorb® MTX is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Polynovo Biomaterials Pty, Ltd.. The 510(k) number is K242149.
When was NovoSorb® MTX approved by the FDA?
NovoSorb® MTX received FDA 510(k) clearance on 2025-03-05, under approval number K242149.
What company makes NovoSorb® MTX?
NovoSorb® MTX is manufactured by Polynovo Biomaterials Pty, Ltd..
What is the FDA product code for NovoSorb® MTX?
The FDA product code for NovoSorb® MTX is QSZ.
Other Devices by Polynovo Biomaterials Pty, Ltd.
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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.