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

Volume: 368, Issue: 2, Pages: 97 - 100
Published: Jan 10, 2013
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...
Paper Details
Title
The 510(k) Ancestry of a Metal-on-Metal Hip Implant
Published Date
Jan 10, 2013
Volume
368
Issue
2
Pages
97 - 100
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