FDA 510(k)

restor3d TIDAL Lumbar Interbody Fusion System

K-Number: K234087 · 2024-01-22

Decision Date2024-01-22

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

restor3d TIDAL Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2024-01-22 under 510(k) number K234087. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the restor3d TIDAL Lumbar Interbody Fusion System?

restor3d TIDAL Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2024-01-22. The listed applicant is Restor3D. The 510(k) number is K234087.

When did restor3d TIDAL Lumbar Interbody Fusion System receive FDA 510(k) clearance?

restor3d TIDAL Lumbar Interbody Fusion System received FDA 510(k) clearance on 2024-01-22, under 510(k) number K234087.

Who is the listed applicant for restor3d TIDAL Lumbar Interbody Fusion System?

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

What is the FDA product code for restor3d TIDAL Lumbar Interbody Fusion System?

The FDA product code for restor3d TIDAL Lumbar Interbody Fusion System is MAX.

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 NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING

Other records listing Restor3D as applicant

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Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.