Dynafix Compression Bone Screw

No FDA recalls on record, checked 22 Oct 2026.

Full name

Ebi Dynafix Compression Bone Screw

510(k) Number

K030706 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Ebi, L.P. →

• What is the Dynafix Compression Bone Screw used for?

  The Dynafix Compression Bone Screw is designed to provide stable internal fixation for bone fragments during orthopedic surgeries. It helps maintain proper alignment and compression of bone segments during the healing process, ensuring secure reduction while bones consolidate. This makes it ideal for procedures where stable fixation is critical to successful bone repair.

• Is the Dynafix Compression Bone Screw sterile and single-use?

  Yes, the Dynafix Compression Bone Screw is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination, adhering to strict medical device sterility protocols. Single-use also eliminates the need for reprocessing, maintaining device integrity between uses.

• What sizes and configurations are available for the Dynafix Compression Bone Screw?

  The Dynafix Compression Bone Screw is manufactured in multiple sizes and configurations to accommodate various orthopedic applications. While exact dimensions are not specified here, the device is designed to be versatile for different surgical needs, ensuring compatibility with a range of bone fixation scenarios. For precise sizing details, refer to the manufacturer’s technical documentation or contact Ebi, L.P.

• How should the Dynafix Compression Bone Screw be stored?

  The Dynafix Compression Bone Screw must be stored and handled according to sterile medical device protocols to preserve its integrity and safety before use. This includes maintaining proper packaging, avoiding contamination, and adhering to temperature and humidity guidelines provided by the manufacturer. Improper storage could compromise sterility or device performance.

• What regulatory approval does the Dynafix Compression Bone Screw hold?

  The Dynafix Compression Bone Screw holds FDA 510(k) clearance under the reference number K030706. This classification confirms it meets regulatory standards for safety and effectiveness as a Class II medical device, specifically for use in orthopedic fixation procedures. The clearance was granted by the FDA’s Orthopedic Advisory Committee in 2003.