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FDA 510(k)

TORPEDO Implant System®

K-Number: K230817 · 2024-01-19

ApplicantDeltacor GmbH
Decision Date2024-01-19
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORPEDO Implant System® is a medical device manufactured by Deltacor GmbH. It received FDA 510(k) clearance on 2024-01-19 under approval number K230817. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORPEDO Implant System®?

TORPEDO Implant System® is a medical device that received FDA 510(k) clearance on 2024-01-19. It is manufactured by Deltacor GmbH. The 510(k) number is K230817.

When was TORPEDO Implant System® approved by the FDA?

TORPEDO Implant System® received FDA 510(k) clearance on 2024-01-19, under approval number K230817.

What company makes TORPEDO Implant System®?

TORPEDO Implant System® is manufactured by Deltacor GmbH.

What is the FDA product code for TORPEDO Implant System®?

The FDA product code for TORPEDO Implant System® is OUR.

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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: OUR)

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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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