Hoffmann II Carbon Connecting Rod

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K961916 ↗

FDA Product Code

JEC

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 Howmedica Corp. →

• What is the Hoffmann II Carbon Connecting Rod used for?

  The Hoffmann II Carbon Connecting Rod is an orthopedic component designed for traction and invasive procedures. It is manufactured from carbon fiber reinforced material and serves as a connecting rod in orthopedic applications.

• Is the Hoffmann II Carbon Connecting Rod single-use or reusable?

  The Hoffmann II Carbon Connecting Rod can be supplied as either a single-use or reusable component, depending on the specific application requirements. This flexibility allows for adaptation to different clinical scenarios.

• What sizes are available for the Hoffmann II Carbon Connecting Rod?

  The Hoffmann II Carbon Connecting Rod is available in various sizes as specified by the manufacturer. The specific size options would be determined based on the clinical needs of the procedure and patient requirements.

• What is the regulatory classification of the Hoffmann II Carbon Connecting Rod?

  The Hoffmann II Carbon Connecting Rod is regulated under FDA 510(k) clearance with product code JEC and is classified as a Class II device for orthopedic use. This indicates it has special controls for safety and effectiveness.