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FDA 510(k)

Two-Step Implant System

K-Number: K181898 · 2018-10-26

ApplicantTrilliant Surgical
Decision Date2018-10-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Two-Step Implant System is a medical device manufactured by Trilliant Surgical. It received FDA 510(k) clearance on 2018-10-26 under approval number K181898. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Two-Step Implant System?

Two-Step Implant System is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Trilliant Surgical. The 510(k) number is K181898.

When was Two-Step Implant System approved by the FDA?

Two-Step Implant System received FDA 510(k) clearance on 2018-10-26, under approval number K181898.

What company makes Two-Step Implant System?

Two-Step Implant System is manufactured by Trilliant Surgical.

What is the FDA product code for Two-Step Implant System?

The FDA product code for Two-Step Implant System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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 Trilliant Surgical

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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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