FDA 510(k)

Two-Step Implant System

K-Number: K181898 · 2018-10-26

Decision Date2018-10-26

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Two-Step Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical. It received FDA 510(k) clearance on 2018-10-26 under 510(k) 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. The listed applicant is Trilliant Surgical. The 510(k) number is K181898.

When did Two-Step Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for Two-Step Implant System?

The FDA 510(k) record lists Trilliant Surgical as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Trilliant Surgical as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.