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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 a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2025-03-24 under approval 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. It is manufactured by Restor3D, Inc.. The 510(k) number is K242356.

When was TIDAL Fusion Cage System approved by the FDA?

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

What company makes TIDAL Fusion Cage System?

TIDAL Fusion Cage System is manufactured by Restor3D, Inc..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT02962570 On-Demand Oxygen Delivery System Study ACTIVE_NOT_RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Other Devices by Restor3D, Inc.

K201314Restor3d Utility Wedge K201393restor3d MTP Implant K240591restor3d Kinos Axiom Total Ankle System K252067Velora Acetabular System K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

Related Devices (Code: SAI)

K230088Ankle Truss System (ATS)4Web Medical, 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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