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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinal channeling instrument, vertebroplasty
Regulation Description Orthopedic manual surgical instrument.
Definition Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.
Product CodeOCJ
Regulation Number 888.4540
Device Class 1

Device Problems
Break 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Apr-27-2011

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