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U&I Corp.

Also registered as U&I Corporation

South KoreaFDA 510(k) applicant, unverified

Devices
35
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What U&I Corp. makes

U&I Corp. manufactures spinal fixation systems, including interbody fusion devices like the VELOFIX™ and VELO™ systems, as well as anterior cervical plates and modifications to spinal fixation hardware. Their portfolio also includes orthopedic implants such as the DYNA Locking Trochanteric Nail, cannulated screws, intramedullary (IM) nails, and ankle nails for fracture fixation. Additionally, they produce joint replacement systems, including the OPTIGEN Total Knee System and the ASPIRON ACP (Articular Cartilage Preservation) System.

The company’s devices are classified under Class II by the FDA and are listed via the 510(k) pathway. Their products are registered in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. U&I Corp. is based in the United States.

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

Catalogue35

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FDA recalls2

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

FDA recall records list 2 recalls initiated by U&I Corp., the earliest on 2019-01-30 and the most recent on 2020-05-26. By recorded status: 2 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 1
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2020

    • 26 May 2020 Z-2672-2020 Class II Terminated 6.0x50mm poly-reduction screws were laser etched 6.0x45 Distribution: U.S.: AZ Submission number: K173524

  • 2019

    • 30 Jan 2019 Z-1823-2020 Class II Terminated The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians. Distribution: US Nationwide distribution in the state of CA. Submission number: K172424

Frequently asked questions

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

The registry currently lists 35 devices for U&I Corp.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 35 most recently registered devices, U&I Corp. has devices listed in FDA 510(k) (35 devices).

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

Among its 35 most recently registered devices, the classes recorded for U&I Corp.'s devices are Class II. Each device page shows its own class and authorisation.

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

FDA recall records list 2 recalls initiated by U&I Corp., the most recent initiated on 2020-05-26. 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. in the registry?

The most recently registered devices listed for U&I Corp. include VELOFIXTM INTERBODY FUSION SYSTEM, SECULOK™ ACP System, Benefix Interspinous Fixation System and VELOXTM INTERBODY FUSION SYSTEM.

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