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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 the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2019-09-12 under 510(k) 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. The listed applicant is Republic Spine, LLC. The 510(k) number is K190398.

When did Republic Spine Restore Intervertebral Body Fusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Republic Spine Restore Intervertebral Body Fusion System?

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

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

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.

NCT07414745MDT-0123 Japan StudyRECRUITINGNCT07568353Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)NOT_YET_RECRUITINGNCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Related PubMed Literature

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.

PMID: 33778409Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices.JOR spine (2021)

Other records listing Republic Spine, LLC as applicant

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.

K223096Dark Star Deformity Pedicle Screw SystemK212028Dark Star Navigation Instrument SystemK201420Republic Spine Dark Star Spinal SystemK190889Republic Spine Restore Cervical Interbody Fusion SystemK181495Republic Spine Dark Star Spinal System

Related Devices (Code: MAX)

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.

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 CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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