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FDA 510(k)

StimTrial Neuromodulation System

K-Number: K243782 · 2025-07-16

ApplicantBioventus, LLC
Decision Date2025-07-16
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimTrial Neuromodulation System is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K243782. 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 StimTrial Neuromodulation System?

StimTrial Neuromodulation System is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Bioventus, LLC. The 510(k) number is K243782.

When did StimTrial Neuromodulation System receive FDA 510(k) clearance?

StimTrial Neuromodulation System received FDA 510(k) clearance on 2025-07-16, under 510(k) number K243782.

Who is the listed applicant for StimTrial Neuromodulation System?

The FDA 510(k) record lists Bioventus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StimTrial Neuromodulation System?

The FDA product code for StimTrial Neuromodulation System is GZF.

Other records listing Bioventus, LLC 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.

PMA P900009Stimulator, bone growth, non-invasivePMA P170007Acid, hyaluronic, intraarticularK243678TalisMann Neuromodulation SystemK233368Allograft Delivery Device (OFAC-C)K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyK193513SIGNAFUSE Bioactive Bone Graft

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Related Devices (Code: GZF)

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.

K243678TalisMann Neuromodulation SystemBioventus, LLCK232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronixK221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, Inc.K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, 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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