FDA 510(k)

Hexanium® ACIF

K-Number: K193000 · 2020-10-20

Decision Date2020-10-20

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hexanium® ACIF is a medical device manufactured by Spinevision, S.A.S.. It received FDA 510(k) clearance on 2020-10-20 under approval number K193000. 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 Hexanium® ACIF?

Hexanium® ACIF is a medical device that received FDA 510(k) clearance on 2020-10-20. It is manufactured by Spinevision, S.A.S.. The 510(k) number is K193000.

When was Hexanium® ACIF approved by the FDA?

Hexanium® ACIF received FDA 510(k) clearance on 2020-10-20, under approval number K193000.

What company makes Hexanium® ACIF?

Hexanium® ACIF is manufactured by Spinevision, S.A.S..

What is the FDA product code for Hexanium® ACIF?

The FDA product code for Hexanium® ACIF is OVE.

Other Devices by Spinevision, S.A.S.

K180437Hexanium® TLIF K210359Hexanium TLIF K223251Hexanium PLIF K221578Hexanium ACIF

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.