Data / Medical devices / United States / Bioventus LLC
Bioventus LLC: FDA-registered device maker in Durham, NC, United States, 13 510(k) clearances and 2 PMA approvals
Bioventus LLC is registered with the FDA (registration 3009595577) in Durham, NC, United States. It lists 7 device types. The FDA files 13 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009595577
- Address
- 4721 Emperor Blvd Ste 100, Durham, NC, United States, 27703
- Owner or operator
- Bioventus LLC (10040666)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 4, 2012
- Registered through
- 2026
- Brand names listed
- DUROLANE, EXOGEN, EXOGEN 4000J, EXOGEN EXPRESS, Interface, OSTEOMATRIX+, OsteoMatrix, Osteoamp Flowable Access Cannula and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Hyaluronic, Intraarticular | MOZ | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep | LPQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2025 | K243782 | StimTrial Neuromodulation System | GZF | Substantially Equivalent | Bioventus, LLC | accessdata.fda.gov |
| July 3, 2025 | K243678 | TalisMann Neuromodulation System | GZF | Substantially Equivalent | Bioventus, LLC | accessdata.fda.gov |
| June 25, 2024 | K233368 | Allograft Delivery Device (OFAC-C) | FMF | Substantially Equivalent | Bioventus, LLC | accessdata.fda.gov |
| February 23, 2022 | K211965 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | Bioness, Inc. | accessdata.fda.gov |
| June 18, 2020 | K193513 | SIGNAFUSE Bioactive Bone Graft | MQV | Substantially Equivalent | Bioventus | accessdata.fda.gov |
| March 27, 2020 | K200482 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | Bioness, Inc. | accessdata.fda.gov |
| October 31, 2019 | K190047 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | Bioness, Inc. | accessdata.fda.gov |
| November 7, 2016 | K160446 | MCP Bone Putty | MQV | Substantially Equivalent | Biostructures, LLC | accessdata.fda.gov |
| February 20, 2015 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | GZF | Substantially Equivalent | Bioness, Inc. | accessdata.fda.gov |
| January 16, 2015 | K142276 | MCS Bone Graft | MQV | Substantially Equivalent | Biostructures, LLC | accessdata.fda.gov |
| January 10, 2014 | K132071 | BIOACTIVE BONE GRAFT PUTTY | MQV | Substantially Equivalent | Biostructures, LLC | accessdata.fda.gov |
| December 13, 2011 | K112857 | INTERFACE BONE VOID FILLER | MQV | Substantially Equivalent | Biostructures, LLC | accessdata.fda.gov |
| March 24, 2010 | K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | MQV | Substantially Equivalent | Berkeley Advanced Biomaterials, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 29, 2017 | P170007 | DUROLANE | MOZ | 15 | December 23, 2025 | accessdata.fda.gov |
| October 5, 1994 | P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | LOF | 44 | March 6, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Acid, Hyaluronic, Intraarticular
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Stimulator, Bone Growth, Non-Invasive
Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.