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FDA 510(k)

Velofix™ SA Cervical Cage

K-Number: K172424 · 2017-11-22

ApplicantU&I Corporation
Decision Date2017-11-22
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Velofix™ SA Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172424. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velofix™ SA Cervical Cage?

Velofix™ SA Cervical Cage is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is U&I Corporation. The 510(k) number is K172424.

When did Velofix™ SA Cervical Cage receive FDA 510(k) clearance?

Velofix™ SA Cervical Cage received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172424.

Who is the listed applicant for Velofix™ SA Cervical Cage?

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

What is the FDA product code for Velofix™ SA Cervical Cage?

The FDA product code for Velofix™ SA Cervical Cage is OVE.

Other records listing U&I Corporation 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.

K220147Aspiron S ACP SystemK210573Velofix SA Cervical CageK183243Velofix TLIF CageK190067Velofix Interbody Fusion SystemK190053SECULOK™ ACP SystemK181824CBT Screw Fixation System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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