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barrier orthopaedic split sheet
Surgikos
Summary: The barrier orthopaedic split sheet by Surgikos is a sterile drape used in surgical settings to maintain a sterile field. It is primarily utilized by orthopedic surgeons during procedures.
FDA Clearance Information
Pathway
510K
Number
K760896 ↗
Decision Date
January 5, 1977
Product Code
—
Device Class
—
Evidence
0 studies
The barrier orthopaedic split sheet was cleared through the FDA 510(k) pathway on January 5, 1977. Manufactured by Surgikos, it does not have a specific product code or classification.
What It Is
The barrier orthopaedic split sheet is a sterile, disposable drape designed to cover and protect the surgical area during orthopedic procedures. It helps maintain a sterile environment by providing a physical barrier against contaminants. The sheet is typically made from a combination of materials that offer fluid resistance and durability, ensuring it remains intact throughout the procedure.
Clinical Applications
This device is commonly used in orthopedic surgeries, such as joint replacements or fracture repairs, where maintaining a sterile field is critical. It is utilized in hospital operating rooms and ambulatory surgical centers. The sheet is particularly useful in procedures involving large surgical fields, providing comprehensive coverage and protection.
Indications for Use
The barrier orthopaedic split sheet is indicated for use in surgical procedures requiring a sterile field, particularly in orthopedics. It is suitable for patients undergoing surgeries where infection prevention is paramount.
Practical Considerations
The split sheet is typically available in various sizes to accommodate different surgical needs and patient sizes. It is compatible with standard surgical draping techniques and can be easily integrated into existing surgical protocols.
Frequently Asked Questions
What is the barrier orthopaedic split sheet used for?
It is used to maintain a sterile field during orthopedic surgeries by providing a protective barrier against contaminants.
What specialties typically use this device?
Orthopedic surgeons primarily use this device during surgical procedures in hospital operating rooms and surgical centers.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring a sterile field, particularly in orthopedic surgeries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.