Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649833

FEI Number

3001584317

Entity Name

On-X Life Technologies Inc.

City/State/Country

Austin, TX, US

Establishment Address

1300 East anderson Lane, Building B, Austin, TX 78752, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

On-X Life Technologies, Inc (Owner Number: 10022596)

Owner / Operator Contact Address

1300 E. Anderson Lane, Bldg. B, Austin, TX 78752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXN	Probe, Test, Heart-Valve	Cardiovascular	Class 1	870.4500	2016-05-13
NEG	Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	Unknown	Class 3	N/A	2021-12-28
OMX	High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis	Unknown	Class f	N/A	2021-12-28
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-08-17
NEG	Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	Unknown	Class 3	N/A	2021-12-28
KWN	Prosthesis, Wrist, Carpal Lunate	Orthopedic	Class 2	888.3750	2021-12-28
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	Cardiovascular	Class 2	870.3470	2014-09-09
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-12-28
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-08-18
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-12-28
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-12-28
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2021-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

On-X Life Technologies, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0005-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0006-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649833. Last updated year: 2026. Please use registration number 1649833 when referencing this establishment in official correspondence.