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Ebi Xfix Dfs Metaphyseal Correction System

by Ebi, L.P. 510(k)

Active United States

510(k) K001358

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK001358 Date23 May 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ebi Xfix Dfs Metaphyseal Correction System is an external fixation device designed for the treatment of various bone conditions. It is indicated for use in procedures including leg lengthening, osteotomies, arthrodesis, and fracture fixation.

This device is authorized under FDA 510(k) clearance K001358. It is manufactured by Ebi, L.P. and is intended for use in bone conditions amenable to treatment by external fixation.

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