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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 the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) 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. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173131.

When did Rexious Spinal Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Rexious Spinal Fixation System?

The FDA 510(k) record lists Huvexel Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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