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FDA 510(k)

IBS Implant System II

K-Number: K162099 · 2017-02-15

ApplicantInnobiosurg Co., Ltd.
Decision Date2017-02-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IBS Implant System II is a medical device manufactured by Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2017-02-15 under approval number K162099. 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 Implant System II?

IBS Implant System II is a medical device that received FDA 510(k) clearance on 2017-02-15. It is manufactured by Innobiosurg Co., Ltd.. The 510(k) number is K162099.

When was IBS Implant System II approved by the FDA?

IBS Implant System II received FDA 510(k) clearance on 2017-02-15, under approval number K162099.

What company makes IBS Implant System II?

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

What is the FDA product code for IBS Implant System II?

The FDA product code for IBS Implant System II is DZE.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Innobiosurg Co., Ltd.

K153350IBS Implant System K152520Magicore System K173120CCM Abutment System K202418Magic UCLA Abutment System K202479IBS Implant System K201981Magicore System

View all 14 devices →

Related Devices (Code: DZE)

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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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