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FDA 510(k)

Eminent Spine Scoliosis Deformity Pedicle Screw System

K-Number: K242069 · 2024-09-03

ApplicantEminent Spine
Decision Date2024-09-03
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Eminent Spine Scoliosis Deformity Pedicle Screw System is a medical device manufactured by Eminent Spine. It received FDA 510(k) clearance on 2024-09-03 under approval number K242069. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eminent Spine Scoliosis Deformity Pedicle Screw System?

Eminent Spine Scoliosis Deformity Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-09-03. It is manufactured by Eminent Spine. The 510(k) number is K242069.

When was Eminent Spine Scoliosis Deformity Pedicle Screw System approved by the FDA?

Eminent Spine Scoliosis Deformity Pedicle Screw System received FDA 510(k) clearance on 2024-09-03, under approval number K242069.

What company makes Eminent Spine Scoliosis Deformity Pedicle Screw System?

Eminent Spine Scoliosis Deformity Pedicle Screw System is manufactured by Eminent Spine.

What is the FDA product code for Eminent Spine Scoliosis Deformity Pedicle Screw System?

The FDA product code for Eminent Spine Scoliosis Deformity Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Eminent Spine

K221936Standalone ALIF Interbody Fusion System K212701Eminent Spine 3D Cervical Interbody Fusion System K250894Eminent Spine Posterior SI System K241663Eminent Spine 3D Titanium Pedicle Screw System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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