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urethane orthopaedic casting tape
Hexcel Medical
Summary: The urethane orthopaedic casting tape by Hexcel Medical is a medical device used for immobilizing fractures and supporting injured limbs. It is typically used by orthopedic specialists and emergency care providers.
FDA Clearance Information
Pathway
510K
Number
K820890 ↗
Decision Date
June 23, 1982
Product Code
ITG
Device Class
Class 1
Evidence
0 studies
The urethane orthopaedic casting tape was cleared through the FDA 510(k) pathway on June 23, 1982, by Hexcel Medical. It is classified as a Class 1 device under product code ITG.
What It Is
This device is a casting tape made from urethane, designed to immobilize and support fractured or injured limbs. It works by being applied over a limb and hardening to form a rigid support structure. The tape is lightweight, durable, and allows for some degree of breathability, making it a preferred choice over traditional plaster casts.
Clinical Applications
Urethane orthopaedic casting tape is commonly used in orthopedic and emergency medicine settings for the treatment of fractures, sprains, and other musculoskeletal injuries. It is suitable for use in both hospital and outpatient settings, and is often applied by orthopedic surgeons, emergency physicians, and trained healthcare professionals. The tape is particularly useful for pediatric and adult patients requiring immobilization.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring immobilization of fractures or injuries to the limbs. It is suitable for a wide range of musculoskeletal conditions where support and stabilization are needed.
Practical Considerations
The casting tape is available in various widths to accommodate different limb sizes and injury types. It is compatible with standard casting techniques and can be easily molded to the contours of the limb. Clinicians should ensure proper application technique to avoid pressure sores or improper immobilization.
Frequently Asked Questions
What is urethane orthopaedic casting tape used for?
It is used for immobilizing and supporting fractures and injuries to the limbs.
What specialties typically use this device?
Orthopedic specialists and emergency care providers typically use this device.
What are the FDA-cleared indications?
It is indicated for immobilizing fractures and supporting injured limbs.
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.