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FDA 510(k)

Mega Plus MIS Spine System

K-Number: K200981 · 2020-08-11

ApplicantBk Meditech, Co., Ltd.
Decision Date2020-08-11
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mega Plus MIS Spine System is a medical device manufactured by Bk Meditech, Co., Ltd.. It received FDA 510(k) clearance on 2020-08-11 under approval number K200981. 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 Mega Plus MIS Spine System?

Mega Plus MIS Spine System is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Bk Meditech, Co., Ltd.. The 510(k) number is K200981.

When was Mega Plus MIS Spine System approved by the FDA?

Mega Plus MIS Spine System received FDA 510(k) clearance on 2020-08-11, under approval number K200981.

What company makes Mega Plus MIS Spine System?

Mega Plus MIS Spine System is manufactured by Bk Meditech, Co., Ltd..

What is the FDA product code for Mega Plus MIS Spine System?

The FDA product code for Mega Plus MIS 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

Related PubMed Literature

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)

Other Devices by Bk Meditech, Co., Ltd.

K183080Mega Plus Spine System K173180Mega Plus Spine 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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