Forefoot Reconstruction System

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

510(k) Number

K961485 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Corp. →

• What is the Forefoot Reconstruction System used for?

  It is a medical device designed for orthopedic applications, specifically for reconstructive procedures related to the forefoot region.

• Is the device intended for single use?

  Yes, the Forefoot Reconstruction System is supplied as a single-use item for medical use.

• Is the device safe for use in an MRI environment?

  Yes, the device is MRI safe and can be used in an MRI environment.

• Is the device sterilized before use?

  Yes, the device is sterilized for medical use and is ready for use upon delivery.

• What is the regulatory status of this device?

  The device is regulated under FDA 510(k) authorization.