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Clinical Evaluation Systematic Literature Review - Apec-ahc.org

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Portion of Conclusion Section<br />

• Thorough clinical evaluation of the safety and efficacy<br />

of the knee implant can be made through the<br />

systematic evaluation and analysis of <strong>Clinical</strong><br />

<strong>Literature</strong> ,the Risk Analysis and Post Market<br />

Surveillance and other data indicating that the device<br />

functions as intended<br />

• Additional clinical trials are not necessary to establish<br />

the safety and effectiveness of the device<br />

Total Hip Replacement<br />

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

•Stem<br />

32

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