FDA 510(k)

Pangea大腿板系統，Pangea腓骨板系統，Pangea胫骨板系統，Pangea肱骨板系統

K 號：K231262 · 2023-08-18

決定日期2023-08-18

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231262. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System?

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Stryker GmbH. The 510(k) number is K231262.

When did Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System receive FDA 510(k) clearance?

Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231262.

Who is the listed applicant for Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System?

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

What is the FDA product code for Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System?

The FDA product code for Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System is HRS.