Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027669735

FEI Number

3027669735

Entity Name

Bioventus LLC

City/State/Country

Cordova, TN, US

Establishment Address

7101 Goodlett Farms Pkwy, Cordova, TN 38016, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Bioventus LLC (Owner Number: 10040666)

Owner / Operator Contact Address

4721 Emperor Blvd., Suite 100, Durham, NC 27703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P900009

All Registered Proprietary Names

H200 Wireless L360 Thigh System StimRouter Neuromodulation System StimRouter Neuromodulation System Misonix® SonicOne O.R.® Ultrasonic Surgical Aspirator System L300 Go L100 Go GELSYN-3 Vector Elite Misonix® neXus® Ultrasonic Surgical Aspirator System StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit BITS L300 Go TalisMann Neuromodulation System StimRouter Plus Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System H200 Wireless EXOGEN EXPRESS EXOGEN 4000J EXOGEN SAFHS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-07-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-07-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-27
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2021-07-27
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2021-07-27
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-09-29
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-07-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-07-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-27
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2024-01-22
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2022-05-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-09-29
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-09-29
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2021-07-27
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	Class 2	882.1470	2022-07-11
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-07-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-27
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2025-08-18
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2022-10-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-08-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-08-18
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2021-10-13
LPQ	Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep	Orthopedic	Class 2	890.5870	2012-05-04
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	Class 2	890.5870	2012-05-04

Official Correspondent

Kellie Stefaniak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioventus LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009595577	BIOVENTUS LLC	Durham, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3020683829	SUZHOU FAST ATM ELECTRIC CO., LTD	Suzhou Jiangsu, CN
3005344585	ODSTOCK MEDICAL LTD	SALISBURY Wiltshire, GB
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3019892999	CIONIC Facility	Scotts Valley, CA, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027669735. Last updated year: 2026. Please use registration number 3027669735 when referencing this establishment in official correspondence.