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FDA 510(k)

IBS System

K-Number: K220517 · 2022-12-20

ApplicantInnobiosurg Co., Ltd.
Decision Date2022-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IBS System is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2022-12-20 under approval number K220517. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBS System?

IBS System is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K220517.

When was IBS System approved by the FDA?

IBS System received FDA 510(k) clearance on 2022-12-20, under approval number K220517.

What company makes IBS System?

IBS System is manufactured by Innobiosurg Co., Ltd..

What is the FDA product code for IBS System?

The FDA product code for IBS System is DZE.

Other Devices by Innobiosurg Co., Ltd.

K153350IBS Implant System K152520Magicore System K162099IBS Implant System II K173120CCM Abutment System K202418Magic UCLA Abutment System K202479IBS Implant System

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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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