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cap plus equivabone cap dbm
Etex
Summary: The Cap Plus Equivabone Cap DBM is a bone graft substitute used in orthopedic and spinal surgeries. It is primarily used by orthopedic surgeons to support bone healing and regeneration.
FDA Clearance Information
Pathway
510K
Number
K080329 ↗
Decision Date
April 28, 2008
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Cap Plus Equivabone Cap DBM was cleared through the FDA 510(k) pathway on April 28, 2008. Manufactured by Etex, it is classified as a Class 2 medical device.
What It Is
The Cap Plus Equivabone Cap DBM is a demineralized bone matrix (DBM) product used as a bone graft substitute. It is designed to provide a scaffold that supports new bone growth, often used in conjunction with other materials to enhance bone healing. The device is typically employed in orthopedic and spinal surgeries where bone regeneration is needed.
Clinical Applications
This device is commonly used in orthopedic and spinal surgeries, particularly in procedures requiring bone grafting, such as spinal fusion or fracture repair. It is suitable for use in both adult and pediatric patients, depending on the specific clinical scenario. The device is often used in hospitals and surgical centers by orthopedic and spine surgeons.
Indications for Use
The Cap Plus Equivabone Cap DBM is indicated for use in patients who require bone grafting to aid in bone healing and regeneration. It is suitable for conditions such as spinal fusion, fracture repair, and other orthopedic procedures where bone growth is necessary.
Practical Considerations
The device is available in various sizes to accommodate different surgical needs and anatomical sites. It is important to ensure compatibility with other materials used in the procedure. Surgeons should be familiar with the handling and placement techniques to optimize outcomes.
Frequently Asked Questions
What is Cap Plus Equivabone Cap DBM used for?
It is used as a bone graft substitute to support bone healing and regeneration in orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic and spine surgeons commonly use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in bone grafting procedures to aid in bone healing and regeneration, such as in spinal fusion and fracture repair.
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.