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acufex drez communicating drill guide
Acufex Microsurgical
Summary: The Acufex Drez Communicating Drill Guide is a surgical tool used primarily in orthopedic procedures to assist in precise drilling. It is typically used by orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K834350 ↗
Decision Date
March 19, 1984
Product Code
FZX
Device Class
Class 1
Evidence
0 studies
The Acufex Drez Communicating Drill Guide was cleared via the FDA 510k pathway on March 19, 1984. Manufactured by Acufex Microsurgical, it is classified as a Class 1 device under product code FZX.
What It Is
The Acufex Drez Communicating Drill Guide is a specialized surgical instrument designed to facilitate accurate drilling during orthopedic procedures. It helps in aligning and guiding the drill to ensure precision, which is critical in surgeries involving bone fixation or reconstruction. The device is typically used in conjunction with other surgical tools to enhance the accuracy and safety of the procedure.
Clinical Applications
This drill guide is commonly used in orthopedic surgeries, particularly those involving joint repair or reconstruction, such as ACL repairs or other ligament reconstructions. It is utilized in hospital operating rooms by orthopedic surgeons to ensure precise drilling, which is essential for successful surgical outcomes. The device is suitable for use in both adult and pediatric populations, depending on the specific surgical needs.
Indications for Use
The FDA indications suggest that this device is used for procedures requiring precise drilling and alignment in orthopedic surgeries. It is particularly beneficial for patients undergoing surgeries that involve bone or joint repair.
Practical Considerations
The Acufex Drez Communicating Drill Guide is typically compatible with standard orthopedic drills. Surgeons should ensure proper alignment and secure attachment to achieve the best results. Familiarity with the device's handling and integration into surgical procedures is recommended for optimal use.
Frequently Asked Questions
What is the Acufex Drez Communicating Drill Guide used for?
It is used for precise drilling in orthopedic surgeries, such as joint or ligament reconstructions.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise drilling and alignment in 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.