FDA Registration
Active
🇺🇸 United States
Bioventus LLC
Reg #: 3027669735
·
FEI: 3027669735
·
Expires 2026
Products
11
Proprietary Names
23
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- Bioventus LLC
- Registration Number
- 3027669735
- FEI Number
- 3027669735
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7101 Goodlett Farms Pkwy
- City
- Cordova
- State
- TN
- ZIP
- 38016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200482
- PMA Number
- P110005
Owner / Operator
- Firm Name
- Bioventus LLC
- Operator Number
- 10040666
- Address
- 4721 Emperor Blvd., Suite 100
- City
- Durham
- State
- NC
- Postal Code
- 27703
- Country
- US
- Correspondent
- Kellie Stefaniak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-07-27 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2021-07-27 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2021-07-27 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2023-09-29 |
| Acid, Hyaluronic, Intraarticular | MOZ | Class 3 | Unknown | No | 2024-01-22 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2022-05-31 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-09-29 |
| Computerized Cognitive Assessment Aid, Exempt | PTY | Class 2 | Neurology | No | 2022-07-11 |
| Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep | LPQ | Class 2 | Orthopedic | No | 2012-05-04 |
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 2 | Orthopedic | No | 2012-05-04 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2022-06-15 |
Proprietary Names
H200 Wireless
L360 Thigh 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
TalisMann Neuromodulation System
StimRouter Plus
Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System
EXOGEN EXPRESS
EXOGEN 4000J
EXOGEN
SAFHS
SUPARTZ FX
DUROLANE
Misonix® SonaStar® Ultrasonic Surgical Aspirator System
Misonix® BoneScalpel® Ultrasonic Surgical Aspirator System
StimTrial Neuromodulation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device