(15 days)
The Vector Medical, Inc. Vector Targeting System is indicated for use in locating (targeting) screw holes in an intramedullary (IM) nail in order to quickly and accurately guide the drill into the exact position to locate and drill the screw holes. The technique does not require the use of radiographic equipment. Generally these nails are indicated for use in fractures in long bones such as the tibia or humerus, which require longitudinal stabilization.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Vector Targeting System" and outlines its indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.