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Tyrx, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
5
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Tyrx, Inc. makes

Tyrx, Inc. manufactures antibacterial polymer envelopes designed to reduce infection risk in orthopedic and neurological implants, including medium and large-sized versions for spinal and cranial applications, as well as specialized envelopes for pacemakers and implantable cardioverter-defibrillators. Their portfolio includes the AIGIS RX N and AIGIS RX R series for spinal and cranial surgeries, the TYRX Neuro Antibacterial Envelope for neurosurgical implants, and the PIVIT A/B ST and PIVIT A/B ST-R for spinal fixation systems.

The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory authorization in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Tyrx, Inc., initiated on 2016-06-29. By recorded status: 3 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2016

    • 29 Jun 2016 Z-2539-2016 Class II Terminated TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Distribution: US Nationwide Distribution Submission number: K063091
    • 29 Jun 2016 Z-2540-2016 Class II Terminated TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Distribution: US Nationwide Distribution Submission number: K063091
    • 29 Jun 2016 Z-2541-2016 Class II Terminated TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Distribution: US Nationwide Distribution Submission number: K063091

Frequently asked questions

How many devices does Tyrx, Inc. have in the registry?

The registry currently lists 5 devices for Tyrx, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tyrx, Inc.'s devices?

Among its 5 most recently registered devices, Tyrx, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Tyrx, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Tyrx, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Tyrx, Inc.?

FDA recall records list 3 recalls initiated by Tyrx, Inc., the most recent initiated on 2016-06-29. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Tyrx, Inc. in the registry?

The most recently registered devices listed for Tyrx, Inc. include AIGIS RX N (MEDIUM), AIGIS RX N (LARGE), AIGIS RX R PM/ AIGIS RX R ICD, TYRX Neuro Antibacterial Envelope and AIGIS RX N MEDIUM; AIGIS RX N LARGE.

Generated automatically from registry data and not verified by a human reviewer.