Contract manufacturerOn-X Life Technologies Inc. (Austin, TX)TexasOrthopedicClass IIClass IIIHDE
On-X Life Technologies Inc.
Contract manufacturer ยท Austin, TX
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1649833 (openFDA record; or search FDA's registration database)
- FEI number
- 3001584317
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- On-X Life Technologies, Inc (FDA owner/operator no. 10022596)
- Registered address
- 1300 East anderson Lane, Building B, Austin, TX 78752
- Contract listings
- 6 device listings, 4 product codes, first listed Dec 28, 2021
- 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 |
|---|---|---|---|---|---|
| KWN | Prosthesis, Wrist, Carpal Lunate | Class II | Orthopedic | Contract manufacturing | Dec 28, 2021 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Class II | Orthopedic | Contract manufacturing | Dec 28, 2021 |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | Class III | Orthopedic | Contract manufacturing | Dec 28, 2021 |
| OMX | High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis | HDE | Orthopedic | Contract manufacturing | Dec 28, 2021 |