Atlas FDA

TalisMann Neuromodulation System

FDA 510(k) clearance K243678 · decided 2025-07-03

Clearance details

K-number
K243678
Device name
TalisMann Neuromodulation System
Applicant
Bioventus, LLC
Decision
Substantially Equivalent
Date received
2024-11-27
Decision date
2025-07-03
Days to decision
218 days
Clearance type
Traditional
Product code
GZF
Device class
2
Regulation number
882.5870
Medical specialty
Neurology
Advisory committee
Neurology
Location
Durham, NC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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StimTrial Neuromodulation System (K243782)Bioventus, LLC2025-07-16
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StimRouter Neuromodulation System (K211965)Bioness, Inc.2022-02-23
Neuspera Neurostimulation System (NNS) (K202781)Neuspera Medical, Inc.2021-08-27
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (K200848)Micron Medical Corporation2020-08-14
StimRouter Neuromodulation System (K200482)Bioness, Inc.2020-03-27
StimRouter Neuromodulation System (K190047)Bioness, Inc.2019-10-31
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435)Nalu Medical, Inc.2019-09-06
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Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (K171366)Stimwave Technologies Inc., Dba Stimq, LLC2017-08-04

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
DUROLANE (P170007/S015)Bioventus, LLC2025-12-23
EXOGEN® Ultrasound Bone Healing System (P900009/S049)Bioventus, LLC2023-12-21
DUROLANE (P170007/S014)Bioventus, LLC2022-10-14
Durolane (P170007/S013)Bioventus, LLC2022-03-03
DUROLANE (P170007/S012)Bioventus, LLC2022-03-02
DUROLANE (P170007/S011)Bioventus, LLC2022-01-25
Exogen (P900009/S048)Bioventus, LLC2022-01-07
DUROLANE (P170007/S010)Bioventus, LLC2021-12-22