I need some help obtaining test results for a posterior cervical fusion device. Specifically ASTM F1717 static and dynamic testing. I need for my 510(k) submission. Where can I get a competitve company's test results?
I need some help obtaining test results for a posterior cervical fusion device. Specifically ASTM F1717 static and dynamic testing. I need for my 510(k) submission. Where can I get a competitve company's test results?
Some of the information might be available via FOI. You can get a redacted version of the 510(k) or PMA submission from the competitor. Otherwise, you have to obtain their product commerically and do testing.
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