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FDA 510(k)

restor3d TIDAL Lumbar Interbody Fusion System

K-Number: K234087 · 2024-01-22

ApplicantRestor3D
Decision Date2024-01-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

restor3d TIDAL Lumbar Interbody Fusion System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2024-01-22 under approval 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. It is manufactured by Restor3D. The 510(k) number is K234087.

When was restor3d TIDAL Lumbar Interbody Fusion System approved by the FDA?

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

What company makes restor3d TIDAL Lumbar Interbody Fusion System?

restor3d TIDAL Lumbar Interbody Fusion System is manufactured by Restor3D.

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Restor3D

K193491restor3d Metallic Interference Screw K220523restor3d TiDAL Lumbar Interbody Fusion Device K211789restor3d Pin Implants K232595Kinos Axiom Total Ankle System K231458Extremity Staple K223326Axiom PSR System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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