FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

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K Number

K001938

Device Name

VECTOR TARGETING SYSTEM

Manufacturer

VECTOR MEDICAL, INC.

Date Cleared

2000-08-29

(64 days)

Product Code