510(k) Submissions: Current Trends and Tips

Posted 01 February 2016 By Kenneth C. Maxwell II

placeholder+image This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process.

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Categories: Medical Devices, Regulatory strategy, Submission and registration, Features, US, CDRH

Tags: 510(k), Sterilization validation, deficiencies, guidance

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