FDA 510(k)

簡易鎖定硬脊膜內系統（細長型）

K 號：K192710 · 2020-06-24

決定日期2020-06-24

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

The Simple Locking Intramedullary (Slim) System is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2020-06-24 under 510(k) number K192710. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Simple Locking Intramedullary (Slim) System?

The Simple Locking Intramedullary (Slim) System is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Pega Medical, Inc.. The 510(k) number is K192710.

When did The Simple Locking Intramedullary (Slim) System receive FDA 510(k) clearance?

The Simple Locking Intramedullary (Slim) System received FDA 510(k) clearance on 2020-06-24, under 510(k) number K192710.

Who is the listed applicant for The Simple Locking Intramedullary (Slim) System?

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

What is the FDA product code for The Simple Locking Intramedullary (Slim) System?

The FDA product code for The Simple Locking Intramedullary (Slim) System is HSB.

其他以 Pega Medical, 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。

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相關器械（代碼：HSB）

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。

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