FDA 510(k)

PIP修復

K 號：K181192 · 2018-10-22

決定日期2018-10-22

產品代碼JEC

諮詢委員會或

決定相當於

器材摘要

PIP Fix is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2018-10-22 under 510(k) number K181192. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PIP Fix?

PIP Fix is a medical device that received FDA 510(k) clearance on 2018-10-22. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K181192.

When did PIP Fix receive FDA 510(k) clearance?

PIP Fix received FDA 510(k) clearance on 2018-10-22, under 510(k) number K181192.

Who is the listed applicant for PIP Fix?

The FDA 510(k) record lists Hand Biomechanics Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIP Fix?

The FDA product code for PIP Fix is JEC.

其他以 Hand Biomechanics Lab, Inc. 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。

K252020隧道視野內視鏡軟組織釋放系統及HBL刀片組裝 K222490HBL刀片組裝

相關器械（代碼：JEC）

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。

K203605醫療設備註冊文本翻譯（zh-TW）： SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo 系統Anjon Holdings, LLC K192465DigiFix 無菌套件Virak Orthopedics, LLC K171863Anjon Bremer Halo 系統Anjon Holdings, LLC K163028Medline ReNewal 再生處理 Stryker 外固定設備Surgical Instrument Service and Savings, Inc.

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。