510(k) K212755

SIGNUS SACRONAIL® Transsacral Stabilization System by Signus Medizintechnik GmbH — Product Code HWC

K212755 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "SIGNUS SACRONAIL® Transsacral Stabilization System". The FDA issued a decision of Substantially Equivalent on March 10, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.