Ebi Xfix Dynafix System Ha Coated Screws

• • Terminated Z-0528-2020 FDA Class II ·initiated 21 Aug 2019 ·on shared 510(k) K992367

  Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

• • Terminated Z-1823-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K992367 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ebi Spinelink System

  Class II

  FDA 510(k) K964797 Active Cleared 2 May 1997

• Ebi Omega 21 System

  Class II

  FDA 510(k) K990303 Active Cleared 29 Apr 1999

• Ebi X Fix Dynafix System/Ebi Dfs Distal Radius Fixator Sc Bone Screws

  Class II

  FDA 510(k) K961433 Active Cleared 28 Jun 1996

• Ebi Thermal Therapy System

  Class II

  FDA 510(k) K963261 Active Cleared 27 Sep 1996

• Ebi Spinelink Anterior Cervical Spinal System

  Class II

  FDA 510(k) K991092 Active Cleared 29 Apr 1999

• Ebice

  Class II

  FDA 510(k) K953532 Active Cleared 4 Oct 1995

See all devices from Electro-Biology, Inc. →