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FDA 510(k)

U&I, OPTIMA, SPINAL SYSTEM

K-Number: K031585 · 2003-06-27

ApplicantU&I Corp., America
Decision Date2003-06-27
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U&I, OPTIMA, SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corp., America. It received FDA 510(k) clearance on 2003-06-27 under 510(k) number K031585. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U&I, OPTIMA, SPINAL SYSTEM?

U&I, OPTIMA, SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-27. The listed applicant is U&I Corp., America. The 510(k) number is K031585.

When did U&I, OPTIMA, SPINAL SYSTEM receive FDA 510(k) clearance?

U&I, OPTIMA, SPINAL SYSTEM received FDA 510(k) clearance on 2003-06-27, under 510(k) number K031585.

Who is the listed applicant for U&I, OPTIMA, SPINAL SYSTEM?

The FDA 510(k) record lists U&I Corp., America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&I, OPTIMA, SPINAL SYSTEM?

The FDA product code for U&I, OPTIMA, SPINAL SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing U&I Corp., America as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031595U & I AMERICA SPINAL HOOK SYSTEMK024096OPTIMA, SPINAL SYSTEM

Related Devices (Code: MNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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