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510(k) Data Aggregation
(84 days)
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
The Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
The provided text does not contain information about acceptance criteria, device performance, or a study demonstrating that a device meets acceptance criteria. The document is a 510(k) summary for Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws, outlining its indications for use, device description, and substantial equivalence to predicate devices. It also includes an FDA response confirming substantial equivalence.
Therefore, I cannot provide the requested table or answer the specific questions about a study based on the given information.
To answer your request, a document detailing device performance data, acceptance criteria, and specific study methodologies would be required.
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