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FDA 510(k)

CSM Submerged3-L Implant System

K-Number: K173141 · 2018-09-19

ApplicantCsm Implant
Decision Date2018-09-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CSM Submerged3-L Implant System is a medical device manufactured by Csm Implant. It received FDA 510(k) clearance on 2018-09-19 under approval number K173141. 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 CSM Submerged3-L Implant System?

CSM Submerged3-L Implant System is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Csm Implant. The 510(k) number is K173141.

When was CSM Submerged3-L Implant System approved by the FDA?

CSM Submerged3-L Implant System received FDA 510(k) clearance on 2018-09-19, under approval number K173141.

What company makes CSM Submerged3-L Implant System?

CSM Submerged3-L Implant System is manufactured by Csm Implant.

What is the FDA product code for CSM Submerged3-L Implant System?

The FDA product code for CSM Submerged3-L 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)

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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