Data / Medical devices / United States / Bioventus LLC

Bioventus LLC: FDA-registered device maker in Cordova, TN, United States, 6 510(k) clearances and 4 PMA approvals

Name: Bioventus LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bioventus LLC is registered with the FDA (registration 3027669735) in Cordova, TN, United States. It lists 11 device types. The FDA files 6 510(k) clearances and 4 PMA approvals under its listings, the newest dated July 16, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3027669735
Address: 7101 Goodlett Farms Pkwy, Cordova, TN, United States, 38016
Owner or operator: Bioventus LLC (10040666)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: May 4, 2012
Registered through: 2026
Brand names listed: BITS, DUROLANE, EXOGEN, EXOGEN 4000J, EXOGEN EXPRESS, GELSYN-3, H200 Wireless, L100 Go and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Hyaluronic, Intraarticular	MOZ	3	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Computerized Cognitive Assessment Aid, Exempt	PTY	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Exerciser, Powered	BXB	1	Contract manufacturer	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Contract manufacturer	accessdata.fda.gov
Stimulator, Bone Growth, Non-Invasive	LOF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Peripheral Nerve, Implanted (Pain Relief)	GZF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep	LPQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Contract manufacturer	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
February 23, 2022	K211965	StimRouter Neuromodulation System	GZF	Substantially Equivalent	Bioness, Inc.	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
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

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
May 9, 2014	P110005	SINOVIAL (SODIUM HYALURONATE 0.8%)	MOZ	14	July 24, 2026	accessdata.fda.gov
January 24, 2001	P980044	SUPARTZ FX	MOZ	62	September 4, 2026	accessdata.fda.gov
October 5, 1994	P900009	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A	LOF	44	March 6, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 17, 2020	87002	Class II	Terminated	EXOGEN Ultrasound Coupling Gel	Product may contain white particulates that are microbial in nature.	accessdata.fda.gov
February 13, 2019	82294	Class II	Terminated	BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTE	The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.	accessdata.fda.gov

Compare with other makers

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.