FDA 510(k)

Velofix SA Cervical Cage

K-Number: K210573 · 2021-11-19

Decision Date2021-11-19

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Velofix SA Cervical Cage is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2021-11-19 under approval number K210573. 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 2021-11-19. It is manufactured by U&I Corporation. The 510(k) number is K210573.

When was Velofix SA Cervical Cage approved by the FDA?

Velofix SA Cervical Cage received FDA 510(k) clearance on 2021-11-19, under approval number K210573.

What company makes Velofix SA Cervical Cage?

Velofix SA Cervical Cage is manufactured by U&I Corporation.

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

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

Other Devices by U&I Corporation

K162189ANAX 5.5 Spinal System K173524ANAX 5.5 Spinal System K172419Velofix TLIF Cage K172424Velofix SA Cervical Cage K171749Velofix(tm) Interbody Fusion System K181824CBT Screw Fixation System

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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.