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FDA 510(k)

Rexious Spinal Fixation System

K-Number: K173131 · 2017-12-08

ApplicantHuvexel Co. , Ltd.
Decision Date2017-12-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rexious Spinal Fixation System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-08 under approval number K173131. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rexious Spinal Fixation System?

Rexious Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K173131.

When was Rexious Spinal Fixation System approved by the FDA?

Rexious Spinal Fixation System received FDA 510(k) clearance on 2017-12-08, under approval number K173131.

What company makes Rexious Spinal Fixation System?

Rexious Spinal Fixation System is manufactured by Huvexel Co. , Ltd..

What is the FDA product code for Rexious Spinal Fixation System?

The FDA product code for Rexious Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Huvexel Co. , Ltd.

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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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