đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during surgical procedures requiring a sterile field.
- Use as a sterile barrier during orthopedic surgical procedures.
- Use to cover and protect the operative area from contamination.
Clinical Applications
- Draping the operative field during joint replacement surgery.
- Draping the patient during fracture repair.
- Providing coverage during orthopedic procedures involving a large surgical field.
- Use in hospital operating rooms and ambulatory surgical centers when a sterile surgical drape is required.
Practical Considerations
- Select a sheet size and configuration that provide complete coverage of the patient and operative field.
- Confirm the package is intact and the drape is sterile before use; do not use it if the package is damaged or the product is expired.
- Follow the facility's sterile-draping technique and avoid creating gaps or tension that could expose the operative field.
- The drape is intended for single use and should be discarded after the procedure; it should not be resterilized or reused.
- MRI compatibility is not established from the available record. Review the specific product labeling and confirm that the drape contains no components that could pose an MRI hazard.
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.