FDA 510(k)

QUANTUM® 病患特定儀器設備（PSI）系統

K 號：K231699 · 2024-04-23

決定日期2024-04-23

產品代碼HSN

諮詢委員會或

決定相當於

器材摘要

QUANTUM® Patient Specific Instrumentation (PSI) System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K231699. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QUANTUM® Patient Specific Instrumentation (PSI) System?

QUANTUM® Patient Specific Instrumentation (PSI) System is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is In2bones Sas. The 510(k) number is K231699.

When did QUANTUM® Patient Specific Instrumentation (PSI) System receive FDA 510(k) clearance?

QUANTUM® Patient Specific Instrumentation (PSI) System received FDA 510(k) clearance on 2024-04-23, under 510(k) number K231699.

Who is the listed applicant for QUANTUM® Patient Specific Instrumentation (PSI) System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTUM® Patient Specific Instrumentation (PSI) System?

The FDA product code for QUANTUM® Patient Specific Instrumentation (PSI) System is HSN.

其他以 In2bones Sas 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。

K230313量子病人特定儀器設備（PSI）系統 K211883QUANTUM® 病患特定儀器設備（PSI）系統 K191380量子® 全踝人工關節 K173811TRIWAY 膝踝跟骨融合系統 (TTC)K173616DIP關節融合系統 K170688PIT’Stop® 假植

查看所有 14 項裝置 →

相關器械（代碼：HSN）

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。

K253159預言環繞外科計劃系統Wright Medical Technology, Inc. (Stryker)K252454金諾斯全腳踝系統Restor3D K250037Incompass 全踝系統Wright Medical Technology, Inc. (Stryker)K250641APEX 3D 全踝關節置換系統Paragon 28, Inc.K240475後曼系列 H2 全腳踝系統Vilex, LLC K241999預言外科計劃系統Wright Medical Technology, Inc. (Stryker)

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。