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integra tm cusa nxt tm bone tips
Integra Burlington Ma, Inc. (Formerly Integra Radi
Summary: The Integra CUSA NXT Bone Tips are surgical tools used for precise bone dissection and removal. They are primarily used by neurosurgeons and orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K111741 ↗
Decision Date
August 23, 2011
Product Code
LFL
Device Class
—
Evidence
0 studies
The Integra CUSA NXT Bone Tips were cleared via the FDA 510k pathway on August 23, 2011. Manufactured by Integra Burlington Ma, Inc., this device falls under the product code LFL.
What It Is
The Integra CUSA NXT Bone Tips are specialized surgical instruments designed for ultrasonic bone cutting and removal. They work by using ultrasonic vibrations to emulsify bone tissue, allowing for precise and controlled bone dissection. This technology minimizes damage to surrounding soft tissues and is particularly useful in complex surgical procedures.
Clinical Applications
These bone tips are commonly used in neurosurgery and orthopedic surgery, particularly in procedures requiring delicate bone removal, such as skull base surgeries or spinal decompressions. They are used in hospital operating rooms and specialized surgical centers, primarily by surgeons trained in advanced surgical techniques. The device is suitable for adult and pediatric populations requiring precise bone removal.
Indications for Use
The FDA indications suggest that the device is intended for use in surgical procedures where precise bone cutting and removal are necessary. This includes conditions requiring access to or removal of bone tissue, such as tumors or deformities.
Practical Considerations
The Integra CUSA NXT Bone Tips come in various sizes to accommodate different surgical needs and anatomical areas. They are compatible with the CUSA NXT system, requiring proper setup and calibration before use. Surgeons should be familiar with ultrasonic surgical techniques to optimize outcomes.
Frequently Asked Questions
What is Integra CUSA NXT Bone Tips used for?
The device is used for precise bone cutting and removal in surgical procedures.
What specialties typically use this device?
Neurosurgeons and orthopedic surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring precise bone dissection and removal.
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.