Novel Vbr Spinal System

• • Terminated Z-0508-2009 FDA Unclassified (pre-2012) ·initiated 16 Aug 2007

  Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.

510(k) Number

K050553 ↗

FDA Product Code

MQP

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Zodiac Spinal Fixation System

  Class II

  FDA 510(k) K050830 Active Cleared 22 Jun 2005

• Zodiac Polyaxial Spinal Fixation System

  Class II

  FDA 510(k) K042673 Active Cleared 27 Oct 2004

• Novel Vbr Spinal System

  Class II

  FDA 510(k) K042201 Active Cleared 7 Oct 2004

• Tamarack Anterior Thoracolunbar

  Class II

  FDA 510(k) K050390 Active Cleared 14 Mar 2005

• Roc Lumbar Plating System

  Class II

  FDA 510(k) K050078 Active Cleared 18 Feb 2005

• Nexflex Total Hip System

  Class II

  FDA 510(k) K042252 Active Cleared 6 Dec 2004

See all devices from Alphatec/Nexmed →