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Clinical Evaluation Systematic Literature Review - Apec-ahc.org

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Total Knee Implant<br />

Knee Implant<br />

Subject of <strong>Clinical</strong> <strong>Evaluation</strong><br />

• Information in this presentation was extracted from a<br />

<strong>Clinical</strong> <strong>Evaluation</strong> <strong>Systematic</strong> <strong>Literature</strong> <strong>Review</strong> to<br />

demonstrate the <strong>Clinical</strong> <strong>Evaluation</strong> <strong>Systematic</strong><br />

<strong>Literature</strong> <strong>Review</strong> Process<br />

• Product is US Class II and cleared by 510(k)--clinical<br />

trial not required and product marketed<br />

•Knee<br />

• May possibly be US Class IIb in the future<br />

• CE Marked as Class III Device<br />

• Some data and details were changed<br />

16

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