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FDA 510(k)

U & I AMERICA SPINAL HOOK SYSTEM

K-Number: K031595 · 2003-06-24

ApplicantU&I Corp., America
Decision Date2003-06-24
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U & I AMERICA SPINAL HOOK 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 2003-06-24 under 510(k) number K031595. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U & I AMERICA SPINAL HOOK SYSTEM?

U & I AMERICA SPINAL HOOK SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is U&I Corp., America. The 510(k) number is K031595.

When did U & I AMERICA SPINAL HOOK SYSTEM receive FDA 510(k) clearance?

U & I AMERICA SPINAL HOOK SYSTEM received FDA 510(k) clearance on 2003-06-24, under 510(k) number K031595.

Who is the listed applicant for U & I AMERICA SPINAL HOOK 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 AMERICA SPINAL HOOK SYSTEM?

The FDA product code for U & I AMERICA SPINAL HOOK SYSTEM is KWP.

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.

K031585U&I, OPTIMA, SPINAL SYSTEMK024096OPTIMA, SPINAL SYSTEM

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

Official Source

View on FDA Database →

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

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