FDA 510(k)

SIGNUS SACRONAIL® Transsacral Stabilization System

K-Number: K212755 · 2022-03-10

Decision Date2022-03-10

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SIGNUS SACRONAIL® Transsacral Stabilization System is a medical device manufactured by Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-03-10 under approval number K212755. 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 SIGNUS SACRONAIL® Transsacral Stabilization System?

SIGNUS SACRONAIL® Transsacral Stabilization System is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Signus Medizintechnik GmbH. The 510(k) number is K212755.

When was SIGNUS SACRONAIL® Transsacral Stabilization System approved by the FDA?

SIGNUS SACRONAIL® Transsacral Stabilization System received FDA 510(k) clearance on 2022-03-10, under approval number K212755.

What company makes SIGNUS SACRONAIL® Transsacral Stabilization System?

SIGNUS SACRONAIL® Transsacral Stabilization System is manufactured by Signus Medizintechnik GmbH.

What is the FDA product code for SIGNUS SACRONAIL® Transsacral Stabilization System?

The FDA product code for SIGNUS SACRONAIL® Transsacral Stabilization System is HWC. This falls under the Cardiovascular category.

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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.