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FDA 510(k)

Hexanium ACIF

K-Number: K221578 · 2022-11-14

ApplicantSpinevision, S.A.S.
Decision Date2022-11-14
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 2022-11-14 under approval number K221578. 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 2022-11-14. It is manufactured by Spinevision, S.A.S.. The 510(k) number is K221578.

When was Hexanium ACIF approved by the FDA?

Hexanium ACIF received FDA 510(k) clearance on 2022-11-14, under approval number K221578.

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 K193000Hexanium® ACIF K210359Hexanium TLIF K223251Hexanium PLIF

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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

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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