SIGNUS SACRONAIL® Transsacral Stabilization System

Screw, Fixation, Bone

SIGNUS Medizintechnik GmbH

The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Signus Sacronail® Transsacral Stabilization System.

Pre-market Notification Details

Device IDK212755
510k NumberK212755
Device Name:SIGNUS SACRONAIL® Transsacral Stabilization System
ClassificationScrew, Fixation, Bone
Applicant SIGNUS Medizintechnik GmbH Industriestrasse 2 Alzenau,  DE 63755
ContactHolger Noss
CorrespondentCarolyn Guthrie
Kapstone Medical, LLC 520 Elliot St. Charlotte,  NC  28202
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-31
Decision Date2022-03-10

NIH GUDID Devices

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