Orthofix

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831576 ↗

FDA Product Code

JEC

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. →