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FDA 510(k)

Republic Spine Restore Intervertebral Body Fusion System

K-Number: K190398 · 2019-09-12

ApplicantRepublic Spine, LLC
Decision Date2019-09-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Republic Spine Restore Intervertebral Body Fusion System is a medical device manufactured by Republic Spine, LLC. It received FDA 510(k) clearance on 2019-09-12 under approval number K190398. 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 Republic Spine Restore Intervertebral Body Fusion System?

Republic Spine Restore Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Republic Spine, LLC. The 510(k) number is K190398.

When was Republic Spine Restore Intervertebral Body Fusion System approved by the FDA?

Republic Spine Restore Intervertebral Body Fusion System received FDA 510(k) clearance on 2019-09-12, under approval number K190398.

What company makes Republic Spine Restore Intervertebral Body Fusion System?

Republic Spine Restore Intervertebral Body Fusion System is manufactured by Republic Spine, LLC.

What is the FDA product code for Republic Spine Restore Intervertebral Body Fusion System?

The FDA product code for Republic Spine Restore Intervertebral Body 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 NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT07585799 Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction RECRUITING

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: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (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 Republic Spine, LLC

K181495Republic Spine Dark Star Spinal System K190889Republic Spine Restore Cervical Interbody Fusion System K212028Dark Star Navigation Instrument System K201420Republic Spine Dark Star Spinal System K223096Dark Star Deformity Pedicle Screw System

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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