FDA 510(k)

Surgify Halo

K-Number: K232684 · 2023-11-29

Decision Date2023-11-29

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Surgify Halo is the device name listed in this FDA 510(k) record. The listed applicant is Surgify Medical OY. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232684. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgify Halo?

Surgify Halo is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Surgify Medical OY. The 510(k) number is K232684.

When did Surgify Halo receive FDA 510(k) clearance?

Surgify Halo received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232684.

Who is the listed applicant for Surgify Halo?

The FDA 510(k) record lists Surgify Medical OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgify Halo?

The FDA product code for Surgify Halo is HBE.

Related Clinical Trials

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.

NCT06827795An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)RECRUITING

Other records listing Surgify Medical OY as applicant

Related Devices (Code: HBE)

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.