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spartan orthopaedic wrist brace model sct-1
Surgitech
Summary: The Spartan Orthopaedic Wrist Brace SCT-1 by Surgitech is a Class 1 medical device used to support and stabilize the wrist. It is typically used by orthopedic specialists and physical therapists for patients with wrist injuries or conditions requiring immobilization.
FDA Clearance Information
Pathway
510K
Number
K031576 ↗
Decision Date
July 31, 2003
Product Code
IQI
Device Class
Class 1
Evidence
0 studies
The Spartan Orthopaedic Wrist Brace SCT-1 was cleared through the FDA 510k process on July 31, 2003. Manufactured by Surgitech, it is classified as a Class 1 device under product code IQI.
What It Is
The Spartan Orthopaedic Wrist Brace SCT-1 is designed to provide support and stabilization to the wrist joint. It is typically made from durable, lightweight materials that allow for adjustable compression and immobilization. The brace is used to aid in the recovery of wrist injuries, such as sprains or fractures, and can also be used post-surgery to ensure proper healing.
Clinical Applications
Commonly used in orthopedic and rehabilitation settings, the Spartan Orthopaedic Wrist Brace SCT-1 is ideal for treating wrist sprains, carpal tunnel syndrome, and post-operative recovery. It is suitable for a wide range of patients, from athletes recovering from sports injuries to individuals with chronic wrist conditions. The brace is often used in outpatient clinics and physical therapy centers.
Indications for Use
The FDA indications suggest that this device is intended for patients who require wrist support due to injury or surgery. It is suitable for conditions such as wrist sprains, fractures, or post-operative immobilization.
Practical Considerations
The Spartan Orthopaedic Wrist Brace SCT-1 typically comes in various sizes to accommodate different wrist circumferences. It is important to ensure a proper fit to maximize support and comfort. The brace is compatible with most standard rehabilitation protocols and can be adjusted for varying levels of compression.
Frequently Asked Questions
What is the Spartan Orthopaedic Wrist Brace SCT-1 used for?
It is used to support and stabilize the wrist in cases of injury, surgery, or chronic conditions requiring immobilization.
What specialties typically use this device?
Orthopedic specialists, physical therapists, and rehabilitation professionals commonly use this device.
What are the FDA-cleared indications?
The device is indicated for providing wrist support and stabilization for injuries, post-surgical recovery, and chronic conditions.
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.