Ebi Vuecath Endoscopic Spinal System

• • Terminated Z-1006-03 FDA Unclassified (pre-2012) ·initiated 17 Jun 2003 ·on shared 510(k) K982484

  Non sterile device is labeled sterile.

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

510(k) Number

K982484 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

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. →