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510(k) K243678

TalisMann Neuromodulation System by Bioventus, LLC — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
November 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5870
Review Panel
NE
Submission Type

Other clearances by Bioventus, LLC

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  • K233368 — Allograft Delivery Device (OFAC-C) (June 25, 2024)
  • K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (December 5, 2023)
  • K193513 — SIGNAFUSE Bioactive Bone Graft (June 18, 2020)
  • K162860 — MCS Bone Graft (February 13, 2017)

Other clearances for product code GZF

  • K243782 — StimTrial Neuromodulation System (July 16, 2025)
  • K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation (August 21, 2024)
  • K233162 — Freedom Peripheral Nerve Stimulator (PNS) System (June 20, 2024)
  • K221303 — Neuspera Nuity System (April 11, 2023)
  • K211965 — StimRouter Neuromodulation System (February 23, 2022)
  • K202781 — Neuspera Neurostimulation System (NNS) (August 27, 2021)
  • K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (August 14, 2020)
  • K200482 — StimRouter Neuromodulation System (March 27, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)
  • K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4 (September 6, 2019)