Contract manufacturerSpinal Systems, LLC (Louisville, KY)KentuckyPhysical medicineClass I
Spinal Systems, LLC
Contract manufacturer · Louisville, KY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3017697442 (openFDA record; or search FDA's registration database)
- FEI number
- 3017697442
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- Spinal Technology, LLC (FDA owner/operator no. 9039913)
- Registered address
- 8075 National Turnpike, Louisville, KY 40214
- Contract listings
- 6 device listings, 6 product codes, first listed Dec 16, 1999
- 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 |
|---|---|---|---|---|---|
| IPT | Orthosis, Thoracic | Class I | Physical medicine | Contract manufacturing | Dec 11, 2019 |
| IPY | Orthosis, Lumbo-Sacral | Class I | Physical medicine | Contract manufacturing | Dec 11, 2019 |
| IQE | Orthosis, Lumbar | Class I | Physical medicine | Contract manufacturing | Dec 16, 1999 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | Class I | Physical medicine | Contract manufacturing | Dec 11, 2019 |
| ISS | Prosthesis, Thigh Socket, External Component | Class I | Physical medicine | Contract manufacturing | Nov 18, 2025 |
| MRI | Orthosis, Truncal/Orthosis, Limb | Class I | Physical medicine | Contract manufacturing | Dec 11, 2019 |