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sygnal dbm
Musculoskeletal Transplant Foundation
Summary: Sygnal DBM is a demineralized bone matrix used in orthopedic procedures to aid in bone healing and regeneration. It is typically used by orthopedic surgeons and other specialists in musculoskeletal care.
FDA Clearance Information
Pathway
510K
Number
K080405 ↗
Decision Date
August 28, 2008
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Sygnal DBM was cleared via the FDA 510k pathway on August 28, 2008, by the Musculoskeletal Transplant Foundation. It is classified as a Class 2 device under product code MBP.
What It Is
The Sygnal DBM is a demineralized bone matrix product designed to support bone healing and regeneration. It is composed of processed human bone tissue, which has been treated to remove minerals, leaving behind a collagen matrix that can stimulate new bone growth. This device is particularly useful in orthopedic and spinal surgeries where bone grafting is necessary.
Clinical Applications
Sygnal DBM is commonly used in orthopedic surgeries, including spinal fusion, fracture repair, and joint reconstruction. It is particularly beneficial in cases where bone grafting is required to enhance bone healing and structural support. The device is used in both inpatient and outpatient settings, and is applicable to a wide range of patient populations, including those with degenerative bone conditions or traumatic injuries.
Indications for Use
The FDA-cleared indications for Sygnal DBM involve its use as a bone graft substitute to aid in bone regeneration. It is suitable for patients undergoing orthopedic surgeries where bone healing is necessary, such as spinal fusions or fracture repairs.
Practical Considerations
Sygnal DBM is available in various forms and sizes to accommodate different surgical needs. It is compatible with standard surgical techniques for bone grafting and can be used in conjunction with other orthopedic implants. Clinicians should ensure proper handling and storage to maintain its efficacy.
Frequently Asked Questions
What is Sygnal DBM used for?
Sygnal DBM is used as a bone graft substitute to promote bone healing and regeneration in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and spine specialists commonly use this device in procedures requiring bone grafting.
What are the FDA-cleared indications?
Sygnal DBM is indicated for use as a bone graft substitute to aid in bone regeneration during 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.