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Published on 13 Sep 2023 on Zacks via Yahoo Finance

Stryker (SYK) Gets FDA 501k Clearance for Pangea Trauma Systems


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Stryker SYK announced that it has gained 510k clearance from the FDA for its Pangea systems, including Femur, Fibula, Tibia, Humerus and Utility.

The FDA clearance for Pangea systems will boost Stryker’s comprehensive portfolio of devices for a wide range of trauma needs.

The Pangea systems is an intuitive and streamlined instrumentation and implant tray that includes 20 anatomic plates and 13 utility plates accessible under one platform. The systems has been designed collaboratively by world-renowned orthopaedic surgeons who offered an evidence-based design for implant fit. It will offer solutions that will enhance plate fit and screw placement. The systems will also include anatomically contoured implants in patient populations with a wide variety of fracture patterns.

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