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FDA 510(k)

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System

K-Number: K200245 · 2020-04-24

ApplicantMedos International Sàrl
Decision Date2020-04-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is a medical device manufactured by Medos International Sàrl. It received FDA 510(k) clearance on 2020-04-24 under approval number K200245. 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 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Medos International Sàrl. The 510(k) number is K200245.

When was EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System approved by the FDA?

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System received FDA 510(k) clearance on 2020-04-24, under approval number K200245.

What company makes EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is manufactured by Medos International Sàrl.

What is the FDA product code for EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System?

The FDA product code for EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System is NKB.

Related Clinical Trials

NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING 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 NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Other Devices by Medos International Sàrl

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems K231527TriALTIS Navigation Enabled Instruments K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments

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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