(133 days)
Omnitech System: The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.
EasyLock Osteosystem & Xtremities: The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.
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The provided text is a 510(k) summary for medical devices (Omnitech and Easy Lock Osteosystem). It describes the intended use and establishes substantial equivalence to predicate devices. It does not contain information on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory submission and equivalence, not on performance study details.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.