Ortho Panel Endorses Class II Status For Posterior Cervical Screws
This article was originally published in The Gray Sheet
Executive Summary
FDA sought panel input on the previously unclassified devices in response to a 2011 petition from the Orthopedic Surgical Manufacturers Association.
You may also be interested in...
FDA Issues Guidance For Small Businesses To Comply With Posterior Cervical Screw Systems Rule
The guidance points small medtech companies that may not have a robust regulatory staff to 510(k) special controls requirements for posterior cervical screw systems. The rule was implemented last year after years of discussion between the US agency and industry stakeholders.
Class II Proposed For Posterior Cervical Screws
The systems, which are used to treat spinal fractures and degenerative disease – among other conditions – are unclassified pre-amendment devices that have reached market via 510(k). FDA is proposing that multiple warnings be added to the product labeling as part of the reclassification.
Regulatory News In Brief
News on a Synthes sentencing, Riata recall and other regulatory developments.