Manta Ray Anterior Cervical Plate System

• • Terminated Z-2197-2011 FDA Unclassified (pre-2012) ·initiated 10 Jan 2011

  Based upon the results of the firm's literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adverse events.

• • Terminated Z-0087-2011 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures.

510(k) Number

K080690 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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