510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243678Substantially Equivalent

TalisMann Neuromodulation System

Bioventus LLC, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243678 is the FDA 510(k) clearance record for TalisMann Neuromodulation System, a class II device, cleared for Bioventus, LLC on under FDA product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)). FDA records list 6 510(k) clearances for Bioventus, LLC, from to . As of , FDA records show no recalls naming K243678.

Clearance record

Decision date
Received
(218 days to decision)
Product code
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Applicant
Bioventus, LLC 4721 Emperor Blvd., Suite 100, Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZF

Trailing 12 months
1 clearance under product code GZF in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260