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U&I Corp., America

United StatesFDA 510(k) applicant, unverified

Devices
3
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What U&I Corp., America makes

U&I Corp. manufactures spinal fixation systems, including the OPTIMA Spinal System and the U & I America Spinal Hook System, designed for surgical stabilization of the spine. These products are intended for use in orthopedic procedures to support vertebral alignment and structural integrity.

The company’s spinal systems are classified as Class II medical devices under FDA regulations and are listed in the 510(k) clearance registry. These products are intended for use within the United States.

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

Catalogue3

Newest first, rows 1-3 of 3

FDA recalls5

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

FDA recall records list 5 recalls initiated by U&I Corp., America, the earliest on 2003-08-18 and the most recent on 2004-08-10. By recorded status: 5 terminated. The reasons filed fall into these groups: mechanical integrity. 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.

  • 2004

    • 10 Aug 2004 Z-1438-04 Unclassified (pre-2012) Terminated Threads on a set screw, as a component of a spinal fixation system, may break off during use. Distribution: CA Submission numbers: K020279, K024096, K031585, K031595
    • 14 Jan 2004 Z-0558-04 Unclassified (pre-2012) Terminated Reports of hex driver tips breaking off or becoming worn or stripped. Distribution: MN Submission numbers: K020279, K024096, K031585, K031595
    • 14 Jan 2004 Z-0559-04 Unclassified (pre-2012) Terminated Reports of hex driver tips breaking off or becoming worn or stripped. Distribution: MN Submission numbers: K020279, K024096, K031585, K031595

  • 2003

    • 18 Aug 2003 Z-1182-03 Unclassified (pre-2012) Terminated Reports of pieces chipping off the tip of screwdriver during use. Distribution: MN Submission numbers: K020279, K031585
    • 18 Aug 2003 Z-1183-03 Unclassified (pre-2012) Terminated Reports of pieces chipping off the tip of screwdriver during use. Distribution: MN Submission number: K031585

Frequently asked questions

How many devices does U&I Corp., America have in the registry?

The registry currently lists 3 devices for U&I Corp., America. Devices recorded under merged duplicate company entries are counted once.

Which registries list U&I Corp., America's devices?

Among its 3 most recently registered devices, U&I Corp., America has devices listed in FDA 510(k) (3 devices).

What risk classes do U&I Corp., America's devices fall under?

Among its 3 most recently registered devices, the classes recorded for U&I Corp., America's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for U&I Corp., America?

FDA recall records list 5 recalls initiated by U&I Corp., America, the most recent initiated on 2004-08-10. 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 U&I Corp., America in the registry?

The most recently registered devices listed for U&I Corp., America include OPTIMA, SPINAL SYSTEM, U & I AMERICA SPINAL HOOK SYSTEM and U&I, OPTIMA, SPINAL SYSTEM.

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