Mantis Spinal System

• 2 recalls, same reason

  • Terminated Z-1611-2009 FDA Unclassified (pre-2012) ·initiated 30 Apr 2009
  • Terminated Z-1612-2009 FDA Unclassified (pre-2012) ·initiated 30 Apr 2009

  The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.

510(k) Number

K061813 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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