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FDA 510(k)

INNO SLA Mini Plus® Implant System

K-Number: K241127 · 2024-12-27

ApplicantCowellmedi Co., Ltd.
Decision Date2024-12-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INNO SLA Mini Plus® Implant System is a medical device manufactured by Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2024-12-27 under approval number K241127. 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 INNO SLA Mini Plus® Implant System?

INNO SLA Mini Plus® Implant System is a medical device that received FDA 510(k) clearance on 2024-12-27. It is manufactured by Cowellmedi Co., Ltd.. The 510(k) number is K241127.

When was INNO SLA Mini Plus® Implant System approved by the FDA?

INNO SLA Mini Plus® Implant System received FDA 510(k) clearance on 2024-12-27, under approval number K241127.

What company makes INNO SLA Mini Plus® Implant System?

INNO SLA Mini Plus® Implant System is manufactured by Cowellmedi Co., Ltd..

What is the FDA product code for INNO SLA Mini Plus® Implant System?

The FDA product code for INNO SLA Mini Plus® Implant System 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 Cowellmedi Co., Ltd.

K201323INNO SLA Submerged Implant System K231411INNO SLA Submerged Hybrid Ti-Base System K232546Meta G UCLA Abutment K231395INNO SLA Submerged Narrow Implant System K211554InnoGenic Non-resorbable Membrane K242287SFIT Abutment

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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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