Draft Guidance Announced: 510(k) Submissions for Bone Anchors

FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors, with recommendations for information and testing that should be included in premarket submissions for devices used in the appendicular skeleton for attachment of soft tissue to bone.

This guidance is a reissuance of the Guidance Document for Testing...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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