EBI XFIX DFS Rail System

• • Terminated Z-0527-2013 FDA Class II ·initiated 9 Nov 2012

  It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

510(k) Number

K000083 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification to Ebi Xfix Dfs System

  Class II

  FDA 510(k) K023324 Active Cleared 18 Oct 2002

• Ebi Vuelock Anterior Cervical Plate System

  Class II

  FDA 510(k) K023133 Active Cleared 18 Oct 2002

• Ebi Spinelink - II Spinal Fixation System

  Class II

  FDA 510(k) K031355 Active Cleared 22 Jul 2003

• Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System

  Class II

  FDA 510(k) K032390 Active Cleared 29 Aug 2003

• Array Spinal System Line Extension

  Class II

  FDA 510(k) K061978 Active Cleared 11 Aug 2006

• Ebi P148 Spinal Fixation System

  Class II

  FDA 510(k) K031423 Active Cleared 27 Jun 2003

See all devices from Ebi, L.P. →

• What is the EBI XFIX DFS Rail System used for?

  The EBI XFIX DFS Rail System is intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction, and other bone conditions amenable to treatment by external fixation, as stated in its device description.

• How is the EBI XFIX DFS Rail System supplied and by whom?

  The device is supplied by Ebi, L.P., as indicated in the manufacturer and supplier information within the device data.

• Is the EBI XFIX DFS Rail System a single-use or reusable device?

  The device data does not specify whether the EBI XFIX DFS Rail System is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.

• What regulatory clearance does the EBI XFIX DFS Rail System have?

  The EBI XFIX DFS Rail System has received FDA 510(k) clearance under K000083, as explicitly stated in the authorizations and specifications sections of the device data.

• What is the product classification and code for the EBI XFIX DFS Rail System?

  The device is classified as a Class 2 Orthopedic device with product code KTT, according to the specifications provided in the device data.