BioPoly, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
BioPoly, LLC - FDA 510(k) Cleared Devices
Recent clearances: BioPoly Radial Head Implant, BioPoly Lesser Toe Hemiarthroplasty Implant, BioPoly Great Toe Hemiarthroplasty Implant
3
Total
3
Cleared
0
Denied
BioPoly, LLC has 3 FDA 510(k) cleared medical devices. Based in Fort Wayne, US.
Latest FDA clearance: Mar 2024. Active since 2021. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by BioPoly, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mcra, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - BioPoly, LLC
3 devices