FDA 510(k)

Hexanium ACIF

K-Number: K221578 · 2022-11-14

Decision Date2022-11-14

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hexanium ACIF is the device name listed in this FDA 510(k) record. The listed applicant is Spinevision, S.A.S.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) 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. The listed applicant is Spinevision, S.A.S.. The 510(k) number is K221578.

When did Hexanium ACIF receive FDA 510(k) clearance?

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

Who is the listed applicant for Hexanium ACIF?

The FDA 510(k) record lists Spinevision, S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hexanium ACIF?

The FDA product code for Hexanium ACIF is OVE.

Other records listing Spinevision, S.A.S. 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.

K223251Hexanium PLIF K210359Hexanium TLIF K193000Hexanium® ACIF K180437Hexanium® TLIF

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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.