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FDA 510(k)

DSP Implant System

K-Number: K192839 · 2021-02-11

ApplicantD.S.P Industrial Eireli
Decision Date2021-02-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DSP Implant System is a medical device manufactured by D.S.P Industrial Eireli. It received FDA 510(k) clearance on 2021-02-11 under approval number K192839. 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 DSP Implant System?

DSP Implant System is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by D.S.P Industrial Eireli. The 510(k) number is K192839.

When was DSP Implant System approved by the FDA?

DSP Implant System received FDA 510(k) clearance on 2021-02-11, under approval number K192839.

What company makes DSP Implant System?

DSP Implant System is manufactured by D.S.P Industrial Eireli.

What is the FDA product code for DSP Implant System?

The FDA product code for DSP 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)

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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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