Get the free OPTIFIXTh Absorbable Fixation System - accessdata fda

K1321.34 DEC 1 of 3 2 2013 510(k) Summary 10 July 2013 Optimist Absorbable Fixation System Contact Rashida Pondicherry Senior Regulatory Affairs Specialist Rashida.pondicherrycrbard.com (401) 8258464

How to fill out optifixth absorbable fixation system

How to fill out optifixth absorbable fixation system:

1. Start by thoroughly washing your hands and putting on sterile gloves to maintain a sterile environment.
2. Open the package containing the optifixth absorbable fixation system and lay out all the components on a sterile tray.
3. Inspect the optifixth absorbable fixation system for any damage or defect. If you notice any issues, contact the manufacturer or your healthcare provider for assistance.
4. Identify the appropriate size and shape of the optifixth absorbable fixation system for your specific needs. Ensure that it matches the anatomical structure you intend to use it for.
5. Prepare the anatomical site where the optifixth absorbable fixation system will be applied. Cleanse the area thoroughly with an antiseptic solution and allow it to dry.
6. Carefully position the optifixth absorbable fixation system on the anatomical site, ensuring it aligns properly.
7. Follow the instructions provided by the manufacturer to secure the optifixth absorbable fixation system in place. This may involve tightening screws, adjusting straps, or applying adhesive as necessary.
8. Double-check that the optifixth absorbable fixation system is securely fixed in place and that it provides the desired stability and support.
9. Clean up the surrounding area and dispose of any waste material according to the appropriate medical waste disposal guidelines.
10. Monitor the patient regularly for any signs of discomfort, irritation, or complications related to the optifixth absorbable fixation system. If any issues arise, seek medical assistance.

Who needs the optifixth absorbable fixation system:

1. Patients who have experienced bone fractures or traumas that require stabilization and healing support.
2. Individuals undergoing orthopedic surgeries to correct deformities, such as joint reconstructions or osteotomies.
3. Patients with certain medical conditions that affect bone integrity, such as osteoporosis, osteogenesis imperfecta, or bone tumors.
4. Athletes who require additional support and stability to prevent future injuries or facilitate faster recovery from existing injuries.
5. Individuals with congenital or acquired skeletal deformities that necessitate corrective measures.

Note: It is crucial to consult with a healthcare professional to determine if the optifixth absorbable fixation system is suitable for your specific condition and needs. Proper evaluation and personalized medical advice are essential for optimal treatment outcomes.

For pdfFiller’s FAQs

What is optifixth absorbable fixation system?

The optifixth absorbable fixation system is a type of medical device used for fixing fractured bones.

Who is required to file optifixth absorbable fixation system?

Manufacturers and distributors of the optifixth absorbable fixation system are required to file the necessary paperwork.

How to fill out optifixth absorbable fixation system?

The optifixth absorbable fixation system paperwork must be filled out with accurate and detailed information about the device.

What is the purpose of optifixth absorbable fixation system?

The purpose of the optifixth absorbable fixation system is to provide stable support to fractured bones during the healing process.

What information must be reported on optifixth absorbable fixation system?

Information such as device specifications, manufacturing process, materials used, and potential risks must be reported on the optifixth absorbable fixation system.

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