Danninger PWB pedicle screw PMA submission is first step toward broader Synergy approval.
This article was originally published in The Gray Sheet
Executive Summary
DANNINGER PWB PEDICLE BONE SCREW SYSTEM PMA is slated for submission to FDA "early" this year, the Columbus, Ohio-based company says. The premarket approval application for the PWB (Puno/Winter/Bird) pedicle screw system will be supported by data from a 350-patient study with two-year follow-up, according to Danninger.