FDA Registration
Active
🇺🇸 United States
On-X Life Technologies Inc.
Reg #: 1649833
·
FEI: 3001584317
·
Expires 2026
Products
14
Proprietary Names
17
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- On-X Life Technologies Inc.
- Registration Number
- 1649833
- FEI Number
- 3001584317
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1300 East anderson Lane, Building B
- City
- Austin
- State
- TX
- ZIP
- 78752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141060
- PMA Number
- P000037
Owner / Operator
- Firm Name
- On-X Life Technologies, Inc
- Operator Number
- 10022596
- Address
- 1300 E. Anderson Lane, Bldg. B
- City
- Austin
- State
- TX
- Postal Code
- 78752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe, Test, Heart-Valve | LXN | Class 1 | Cardiovascular | No | 2016-05-13 |
| Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | NEG | Class 3 | Unknown | No | 2021-12-28 |
| High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis | OMX | Class f | Unknown | No | 2021-12-28 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-08-17 |
| Prosthesis, Wrist, Carpal Lunate | KWN | Class 2 | Orthopedic | No | 2021-12-28 |
| Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | PAW | Class 2 | Cardiovascular | No | 2014-09-09 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2021-12-28 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-08-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-12-28 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2021-12-28 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2018-08-27 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2007-10-05 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 2019-12-12 |
Proprietary Names
On-X Heart Valve Instrumentation
Ascension PIP
On-X Intrsuments: handle and rotators
Ascension MCP
Ascension Pyrocarbon Lunate; Integra
Chord-X Pre-measured Loops for Mitral Chordal Replacement
Ascension NuGrip CMC Implant; Integra
On-X Prosthetic Heart Valve
On-X Prosthetic Heart Valve with Anatomic Aortic Sewing Ring
On-X AAP Ascending Aortic Prosthesis
On-X Conform-X Prosthetic Heart Val
Chordal Sizer
Pyro Titan Humeral Resurfacing Arthroplasty
Ensemble CMC
Carbon Modular Radial Head
On-X Instruments: Tray
Ascension Pyrosphere; Integra
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only