A manufacturer submits a 510(k) for

制造商提交了 510(k) 用于固定骨干（长骨的轴）和骨骺（长骨的末端）骨折的接骨板，即该接骨板可用于固定长骨，例如股骨或大腿骨，在中间或末端断裂。制造商引用的谓词装置是仅适用于中间骨骨折的钢板，以及另一种专用于骨尖骨折的谓词装置。虽然每个谓词装置的使用适应症不同，但两种装置具有相同的预期用途，即长骨骨折固定。<br><br>因此，虽然制造商可以使用单一的谓词设备，但如果制造商打算销售一种设备用于多个适应症并且存在不同的谓词来支持每个特定的适应症，制造商可能会引用多个相关的谓词设备来支持 SE 决定。在这种情况下，使用制造商明确标识的两个适当的谓词有助于促进新设备的清除，新设备被指示治疗由谓词治疗的两种类型的骨折。

A manufacturer submits a 510(k) for a plate indicated for fixation of both diaphyseal (the shaft of a long bone) and epiphyseal (the ends of a long bone) fractures, i.e., the plate can be used to set a long bone, such as the femur or thigh bone, that is broken in the middle or at the ends. The manufacturer cites a predicate device that is a plate indicated for middle bone fractures only and another predicate device that is indicated specifically for bone tip fractures. While the indications for use of each predicate device are different, both devices have the same intended use, namely,fracture fixation of the long bone. Thus, although the manufacturer could have used a single predicate device, in cases where a manufacturer intends to market a device for more than one indication and a different predicate exists to support each specific indication, the manufacturer may cite more than one relevant predicate device to support an SE determination. In this case, using two appropriate predicates clearly identified by the manufacturer helped to facilitate clearance of the new device, which was indicated to treat both types of fractures treated by the predicates.<br>

制造商提交了用于固定骨干(长骨的轴)和骨骺(长骨的末端)骨折的板的510(k)，即，该板可用于固定长骨，例如股骨或大腿骨，其在中间或末端断裂。制造商引用了一个仅适用于中部骨折的预测装置和另一个专门适用于骨尖骨折的预测装置。虽然每种预测装置的使用指征不同，但两种装置都有相同的预期用途，即长骨骨折固定。因此，尽管制造商可以使用单个断言设备，但是在制造商打算针对不止一个指示销售设备并且存在不同断言来支持每个特定指示的情况下，制造商可以引用不止一个相关断言设备来支持SE确定。在这种情况下，使用制造商明确标识的两个适当的谓词有助于清除新设备，这表明可以处理谓词处理的两种类型的骨折。