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FDA 510(k)

TIDAL Fusion Cage System

K-Number: K242356 · 2025-03-24

ApplicantRestor3D, Inc.
Decision Date2025-03-24
Product CodeSAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIDAL Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K242356. The device is classified under product code SAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIDAL Fusion Cage System?

TIDAL Fusion Cage System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Restor3D, Inc.. The 510(k) number is K242356.

When did TIDAL Fusion Cage System receive FDA 510(k) clearance?

TIDAL Fusion Cage System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K242356.

Who is the listed applicant for TIDAL Fusion Cage System?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIDAL Fusion Cage System?

The FDA product code for TIDAL Fusion Cage System is SAI.

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.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING

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Related Devices (Code: SAI)

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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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