Ebi Xfix Dfs Optirom Elbow Fixator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992515 ↗

FDA Product Code

KTT

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 Ebi, L.P. →

• What clinical conditions is the Ebi Xfix Dfs Optirom Elbow Fixator designed to treat?

  This device is indicated for the treatment of bone and soft tissue conditions in the upper extremity that are amenable to external fixation. Specifically, it is used for fracture dislocations involving ligamentous instability, comminuted intra-articular fractures, and post-traumatic reconstruction.

• What is the regulatory status of this elbow fixator?

  The Ebi Xfix Dfs Optirom Elbow Fixator is authorized under FDA 510(k) clearance number K992515. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• Who is the intended user for this orthopedic device?

  This device is intended for clinical application exclusively by medical professionals working in orthopedic settings. It is designed for use by trained clinicians who are qualified to perform external fixation procedures on the upper extremity.

• Where can I find specific information regarding sterility and storage for this device?

  Users should consult the official manufacturer documentation provided by Ebi, L.P. for specific requirements regarding sterility, whether the components are intended for single-use or reuse, and the appropriate storage conditions for the device.