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FDA 510(k)

SIGNUS SACRONAIL® Transsacral Stabilization System

K-Number: K212755 · 2022-03-10

ApplicantSignus Medizintechnik GmbH
Decision Date2022-03-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGNUS SACRONAIL® Transsacral Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-03-10 under 510(k) 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. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K212755.

When did SIGNUS SACRONAIL® Transsacral Stabilization System receive FDA 510(k) clearance?

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

Who is the listed applicant for SIGNUS SACRONAIL® Transsacral Stabilization System?

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

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.

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