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FDA 510(k)

INNO SLA Submerged Implant System

K-Number: K201323 · 2022-01-25

ApplicantCowellmedi Co., Ltd.
Decision Date2022-01-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INNO SLA Submerged Implant System is a medical device manufactured by Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2022-01-25 under approval number K201323. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNO SLA Submerged Implant System?

INNO SLA Submerged Implant System is a medical device that received FDA 510(k) clearance on 2022-01-25. It is manufactured by Cowellmedi Co., Ltd.. The 510(k) number is K201323.

When was INNO SLA Submerged Implant System approved by the FDA?

INNO SLA Submerged Implant System received FDA 510(k) clearance on 2022-01-25, under approval number K201323.

What company makes INNO SLA Submerged Implant System?

INNO SLA Submerged Implant System is manufactured by Cowellmedi Co., Ltd..

What is the FDA product code for INNO SLA Submerged Implant System?

The FDA product code for INNO SLA Submerged Implant System is NHA.

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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.

K231411INNO SLA Submerged Hybrid Ti-Base System K232546Meta G UCLA Abutment K231395INNO SLA Submerged Narrow Implant System K211554InnoGenic Non-resorbable Membrane K241127INNO SLA Mini Plus® Implant System K242287SFIT Abutment

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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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