Contract manufacturerWHEELHOUSE MEDICAL (Monroe, NC)North CarolinaRadiologyOrthopedicClass II
WHEELHOUSE MEDICAL
Contract manufacturer ยท Monroe, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3021559833 (openFDA record; or search FDA's registration database)
- FEI number
- 3021559833
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Contract manufacturer
- Owner or operator
- WHEELHOUSE MEDICAL (FDA owner/operator no. 10084227)
- Registered address
- 511 Jim Parker Rd, Monroe, NC 28110
- Contract listings
- 3 device listings, 5 product codes, first listed Jan 27, 2022
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Class II | Radiology | Contract manufacturing | Oct 21, 2024 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | Oct 21, 2024 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 27, 2022 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | Contract manufacturing | Jan 28, 2022 |
| OWB | Interventional Fluoroscopic X-Ray System | Class II | Radiology | Contract manufacturing | Oct 21, 2024 |