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danninger orthopaedic awl
Danninger Medical Technology
Summary: The Danninger Orthopaedic Awl is a surgical tool used primarily in orthopedic procedures to create precise openings in bone. It is typically used by orthopedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K875223 ↗
Decision Date
February 17, 1988
Product Code
HWJ
Device Class
Class 1
Evidence
0 studies
The Danninger Orthopaedic Awl was cleared through the FDA 510(k) pathway on February 17, 1988. Manufactured by Danninger Medical Technology, it is classified as a Class 1 device under product code HWJ.
What It Is
The Danninger Orthopaedic Awl is a surgical instrument designed for orthopedic procedures. It is used to create openings or channels in bone, facilitating the insertion of screws, pins, or other orthopedic hardware. The awl's design allows for precision and control, which is crucial in maintaining the integrity of the surrounding bone structure. This tool is essential in procedures that require accurate bone penetration.
Clinical Applications
The Danninger Orthopaedic Awl is commonly used in orthopedic surgeries, such as fracture fixation, joint replacement, and spinal surgeries. It is particularly useful in settings where precise bone preparation is required, such as in the placement of pedicle screws in spinal surgery. Orthopedic surgeons and surgical teams in hospitals and specialized orthopedic centers frequently use this device.
Indications for Use
The device is indicated for use in creating openings in bone during orthopedic procedures. It is suitable for patients undergoing surgeries that require the insertion of orthopedic hardware, such as screws or pins, to stabilize or repair bone structures.
Practical Considerations
The Danninger Orthopaedic Awl is available in various sizes to accommodate different surgical needs and patient anatomies. It is compatible with standard orthopedic surgical kits and should be used with care to avoid unnecessary damage to bone tissue. Proper technique is essential to ensure optimal outcomes and patient safety.
Frequently Asked Questions
What is the Danninger Orthopaedic Awl used for?
It is used to create precise openings in bone during orthopedic surgeries, facilitating the insertion of screws or pins.
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 creating openings in bone during orthopedic procedures, such as fracture fixation and joint replacement.
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.