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FDA 510(k)

TalisMann Neuromodulation System

K-Number: K243678 · 2025-07-03

ApplicantBioventus, LLC
Decision Date2025-07-03
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TalisMann Neuromodulation System is a medical device manufactured by Bioventus, LLC. It received FDA 510(k) clearance on 2025-07-03 under approval number K243678. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TalisMann Neuromodulation System?

TalisMann Neuromodulation System is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Bioventus, LLC. The 510(k) number is K243678.

When was TalisMann Neuromodulation System approved by the FDA?

TalisMann Neuromodulation System received FDA 510(k) clearance on 2025-07-03, under approval number K243678.

What company makes TalisMann Neuromodulation System?

TalisMann Neuromodulation System is manufactured by Bioventus, LLC.

What is the FDA product code for TalisMann Neuromodulation System?

The FDA product code for TalisMann Neuromodulation System is GZF.

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Related Devices (Code: GZF)

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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.

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