BIOVENTUS LLC

FDA Device Registration & Listing · Durham, NC, US · Registration 3009595577

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009595577
FEI Number
3009595577
Entity Name
BIOVENTUS LLC
City/State/Country
Durham, NC, US
Establishment Address
4721 Emperor Blvd Ste 100, Durham, NC 27703, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bioventus LLC (Owner Number: 10040666)
Owner / Operator Contact Address
4721 Emperor Blvd., Suite 100, Durham, NC 27703, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K112857
PMA Number
N/A

All Registered Proprietary Names

StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit StimRouter Plus OSTEOMATRIX+ OsteoMatrix DUROLANE StimRouter Neuromodulation System Osteoamp Flowable Access Cannula SIGNAFUSE Bioactive Strip TalisMann Neuromodulation System Interface

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2022-10-10
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-11
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2016-04-07
MOZ Acid, Hyaluronic, Intraarticular Unknown Class 3 N/A 2017-10-23
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2021-07-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-09-17
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2025-04-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-06-25
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2025-08-18
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2016-04-07

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
3027669735 Bioventus LLC Cordova, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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3027669735 Bioventus LLC Cordova, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009595577. Last updated year: 2026. Please use registration number 3009595577 when referencing this establishment in official correspondence.
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