FDA 510(k)

DePuy Synthes MAXFRAME 多軸校正系統

K 號：K161417 · 2016-11-10

決定日期2016-11-10

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

DePuy Synthes MAXFRAME Multi-Axial Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA, LLC. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K161417. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes MAXFRAME Multi-Axial Correction System?

DePuy Synthes MAXFRAME Multi-Axial Correction System is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Synthes USA, LLC. The 510(k) number is K161417.

When did DePuy Synthes MAXFRAME Multi-Axial Correction System receive FDA 510(k) clearance?

DePuy Synthes MAXFRAME Multi-Axial Correction System received FDA 510(k) clearance on 2016-11-10, under 510(k) number K161417.

Who is the listed applicant for DePuy Synthes MAXFRAME Multi-Axial Correction System?

The FDA 510(k) record lists Synthes USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes MAXFRAME Multi-Axial Correction System?

The FDA product code for DePuy Synthes MAXFRAME Multi-Axial Correction System is KTT.

其他以 Synthes USA, 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。

K180821TruMatch Graft Cage - 長骨

相關器械（代碼：KTT）

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLC K260900DYNEX® 外固定系統Vilex, LLC K260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean Global K253613猴環外環固定系統Paragon 28, Inc.K253202霍夫曼LRF系統Stryker 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。