Bioventus, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bioventus, LLC - FDA 510(k) Cleared Devices
Recent clearances: StimTrial Neuromodulation System, TalisMann Neuromodulation System, Allograft Delivery Device (OFAC-C)
5
Total
5
Cleared
0
Denied
Bioventus, LLC has 5 FDA 510(k) cleared medical devices. Based in Durham, US.
Latest FDA clearance: Jul 2025. Active since 2017. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Bioventus, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bruder Consulting & Venture Group as regulatory consultant.
FDA 510(k) Regulatory Record - Bioventus, LLC
5 devices
Cleared
Jul 16, 2025
StimTrial Neuromodulation System
Neurology
219d
Cleared
Jul 03, 2025
TalisMann Neuromodulation System
Neurology
218d
Cleared
Jun 25, 2024
Allograft Delivery Device (OFAC-C)
General & Plastic Surgery
267d
Cleared
Dec 05, 2023
SIGNAFUSE Bioactive Strip (SBS)
Orthopedic
39d
Cleared
Feb 13, 2017
MCS Bone Graft
Orthopedic
124d