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an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws. The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation.
This document is a 510(k) summary for a medical device called the "Acumed Retrograde Humeral Nail." It is a pre-market notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with acceptance criteria and a device's performance against them.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth, and study types is not available in the provided text.
The document describes the device, its material, sterilization method, and states its similarity to a predicate device ("Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail") in design, function, indications, and surgical technique, implying that it is expected to perform as well, but it does not provide data from a study to prove this.
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Image /page/0/Picture/1 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are large and blocky, with a slightly rounded appearance. To the right of the word "ACUMED" is the superscript "TM", indicating a trademark. A thick, black line underlines the entire word, adding emphasis to the brand name.
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Quality Orthopaedic Instruments and Implants
OCT 28 1996 Enclosure D - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Retrograde Humeral Nail is an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws.
The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 104. Information regarding implantation, packaging, and labeling have been provided.
The Acumed Retrograde Humeral Nail is similar to Smith & Nephew Richards' Russell-Taylor Humeral Interlocking Nail in design, function, indications, and surgical technince and is expected to perform as well as similar devices. .
§ 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.