Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Republic Spine Restore Cervical Interbody Fusion System

K-Number: K190889 · 2019-06-19

ApplicantRepublic Spine, LLC
Decision Date2019-06-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Republic Spine Restore Cervical Interbody Fusion System is a medical device manufactured by Republic Spine, LLC. It received FDA 510(k) clearance on 2019-06-19 under approval number K190889. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Republic Spine Restore Cervical Interbody Fusion System?

Republic Spine Restore Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-19. It is manufactured by Republic Spine, LLC. The 510(k) number is K190889.

When was Republic Spine Restore Cervical Interbody Fusion System approved by the FDA?

Republic Spine Restore Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-19, under approval number K190889.

What company makes Republic Spine Restore Cervical Interbody Fusion System?

Republic Spine Restore Cervical Interbody Fusion System is manufactured by Republic Spine, LLC.

What is the FDA product code for Republic Spine Restore Cervical Interbody Fusion System?

The FDA product code for Republic Spine Restore Cervical Interbody Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_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 K190398Republic Spine Restore Intervertebral Body Fusion System K212028Dark Star Navigation Instrument System K201420Republic Spine Dark Star Spinal System K223096Dark Star Deformity Pedicle Screw System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

↑