FDA 510(k)

鐳素胸骨電纜板系統

K 號：K193468 · 2020-03-12

申請人Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

決定日期2020-03-12

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

Tritium Sternal Cable Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K193468. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tritium Sternal Cable Plate System?

Tritium Sternal Cable Plate System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K193468.

When did Tritium Sternal Cable Plate System receive FDA 510(k) clearance?

Tritium Sternal Cable Plate System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K193468.

Who is the listed applicant for Tritium Sternal Cable Plate System?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tritium Sternal Cable Plate System?

The FDA product code for Tritium Sternal Cable Plate System is JDQ.