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arthritis, Cobalt chrome, cobalt levels, Cobalt poisoning, Corin, DePuy, DePuy ASR™ Hip Resurfacing System, DePuy Hip Replacement, Federal Food Drug and Cosmetic Act, Food & Drug Administration, hip, Hip recall, Hip Replacement, hip replacement failure, Institute of Medicine, Metal on metal hip, Smith & Nephew, testing, Total Hip Replacement, UNited States
Corin Presentation to FDA Approvals Panel
Ever wonder what they tell the panel to get a 510K approval…
Download presentation here (all 95 pages)
Did you ever wonder how they dealt with the issue of Cobalt Chrome metallosis:
- Two year study – “nothing of significance to report”
- This slide below seems to be the in-depth analysis presented and one might be forgiven for thinking, was accepted… well they 510k was approved this earlier 2011…
- pretty detailed huh…?
- last two bullet points – really … ?
Technorati Tags: Corin Profit, Metal on Metal Hips, Ceramic on Metal Hips, Hip Replacement
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