FDA 510(k)

Freedom DS™ 解壓系統

K 號：K253523 · 2026-04-16

決定日期2026-04-16

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

Freedom DS™ Decompression System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253523. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Freedom DS™ Decompression System?

Freedom DS™ Decompression System is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Spinal Simplicity. The 510(k) number is K253523.

When did Freedom DS™ Decompression System receive FDA 510(k) clearance?

Freedom DS™ Decompression System received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253523.

Who is the listed applicant for Freedom DS™ Decompression System?

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

What is the FDA product code for Freedom DS™ Decompression System?

The FDA product code for Freedom DS™ Decompression System is HRX.

其他以 Spinal Simplicity 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。

K163428HA Minuteman G3-R 医療設備合規文本

相關器械（代碼：HRX）

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。

K260203富麗椎體成形術氣球針管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯內視鏡術望遠鏡Karl Storz SE & CO. KG K252790數位ClarusScope系統及數位NeuroPEN系統Clarus Medical, LLC K252546Vantage™ 腰椎减压套件Allevion Medical, LLC K253217MiiS Horus 鼻喉鏡 (EJA 100)；MiiS Horus 結腸鏡顯示系統 - 平板 (EDS 500)；MiiS Horus 結腸鏡顯示系統 - 遙控盒 (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbH

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。