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The 510(k) Ancestry of a Metal-on-Metal Hip Implant

The 510(k) Ancestry of a Metal-on-Metal Hip Implant Medical device makers have been able to obtain FDA clearance by claiming substantial equivalence to earlier devices (or parts thereof) that may have been cleared the same way. The ancestry of a problematic metal-on-metal hip implant includes 95 different devices. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The New England Journal of Medicine The New England Journal of Medicine

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

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References (2)

Publisher
The New England Journal of Medicine
Copyright
Copyright © 2013 Massachusetts Medical Society. All rights reserved.
ISSN
0028-4793
eISSN
1533-4406
DOI
10.1056/NEJMp1211581
pmid
23301729
Publisher site
See Article on Publisher Site

Abstract

Medical device makers have been able to obtain FDA clearance by claiming substantial equivalence to earlier devices (or parts thereof) that may have been cleared the same way. The ancestry of a problematic metal-on-metal hip implant includes 95 different devices.

Journal

The New England Journal of MedicineThe New England Journal of Medicine

Published: Jan 10, 2013

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