New Era Orthopedics, LLC is one of 18961 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
New Era Orthopedics, LLC - FDA 510(k) Cleared Devices
Recent clearances: Polyscrew Pedicle Screw System, Neo Total Knee System
2
Total
2
Cleared
0
Denied
New Era Orthopedics, LLC has 2 FDA 510(k) cleared medical devices. Based in Hummelstown, US.
Historical record: 2 cleared submissions from 2014 to 2015. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by New Era Orthopedics, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Empirical Testing Corp as regulatory consultant.
FDA 510(k) Regulatory Record - New Era Orthopedics, LLC
2 devices