FDA 510(k)

SNIPER 鋼釘系統，非無菌

K 號：K172405 · 2017-12-11

決定日期2017-12-11

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

SNIPER STAPLE SYSTEM, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K172405. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SNIPER STAPLE SYSTEM, NON-STERILE?

SNIPER STAPLE SYSTEM, NON-STERILE is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Trilliant Surgical. The 510(k) number is K172405.

When did SNIPER STAPLE SYSTEM, NON-STERILE receive FDA 510(k) clearance?

SNIPER STAPLE SYSTEM, NON-STERILE received FDA 510(k) clearance on 2017-12-11, under 510(k) number K172405.

Who is the listed applicant for SNIPER STAPLE SYSTEM, NON-STERILE?

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

What is the FDA product code for SNIPER STAPLE SYSTEM, NON-STERILE?

The FDA product code for SNIPER STAPLE SYSTEM, NON-STERILE is JDR.

其他以 Trilliant Surgical 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。

K212378Arsenal Ankle Plating System K191009Arsenal Plating System K181898雙階段植入系統

相關器械（代碼：JDR）

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。

K262451Arthrex DynaNite 针Arthrex, Inc.K261121巨牙動態壓縮系統Paragon 28, Inc.K250712連結壓縮釘針系統Trax Surgical K243888Medline UNITE® REFLEX® 混合不銹鋼植入系統Medline Industries, LP K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC壓力植入系統Treace Medical Concepts

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。