FDA Registration
Active
🇺🇸 United States
WHEELHOUSE MEDICAL
Reg #: 3021559833
·
FEI: 3021559833
·
Expires 2026
Products
6
Proprietary Names
4
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- WHEELHOUSE MEDICAL
- Registration Number
- 3021559833
- FEI Number
- 3021559833
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 511 Jim Parker Rd
- City
- Monroe
- State
- NC
- ZIP
- 28110
- Country
- US
Owner / Operator
- Firm Name
- WHEELHOUSE MEDICAL
- Operator Number
- 10084227
- Address
- 511 Jim Parker Rd
- City
- Monroe
- State
- NC
- Postal Code
- 28110
- Country
- US
- Correspondent
- John Souza Souza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-10-21 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-10-21 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-10-21 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-10-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-01-27 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2022-01-28 |
Proprietary Names
Wheelhouse Medical Specials
TrackX Cap and Collar
Expandable Titanium PLIF/TLIF System
Spectrum Spine Laminoplasty Plating System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)