FDA 510(k)

塔利斯曼神經調節系統

K 號：K243678 · 2025-07-03

決定日期2025-07-03

產品代碼GZF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

TalisMann 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 2025-07-03 under 510(k) number K243678. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TalisMann Neuromodulation System?

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

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

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

Who is the listed applicant for TalisMann Neuromodulation System?

FDA 510(k) 記錄將 Bioventus, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for TalisMann Neuromodulation System?

The FDA product code for TalisMann Neuromodulation System is GZF.

其他以 Bioventus, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253877刺激試驗神經調節系統 K243782刺激試驗神經調節系統 K233368異種移植與異種移植對水平肺泡脊增高的對比 K233490SIGNAFUSE 生物活性條 (SBS)；SIGNAFUSE 黏土 K162860MCS骨移植材

相關器械（代碼：GZF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253877刺激試驗神經調節系統Bioventus, LLC K243782刺激試驗神經調節系統Bioventus, LLC K232415Nalu神經刺激系統用於週邊神經刺激Boston Scientific Neuromodulation K233162自由周邊神經刺激器（PNS）系統Curonix K221303Neuspera Nuity 系統Neuspera Medical, Inc.K211965StimRouter神經調節系統Bioness, Inc.

官方來源

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