FDA 510(k)

Signus Tetris St; Signus Tetris R St

K-Number: K241438 · 2024-09-11

Decision Date2024-09-11

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Signus Tetris St; Signus Tetris R St is a medical device manufactured by Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2024-09-11 under approval number K241438. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signus Tetris St; Signus Tetris R St?

Signus Tetris St; Signus Tetris R St is a medical device that received FDA 510(k) clearance on 2024-09-11. It is manufactured by Signus Medizintechnik GmbH. The 510(k) number is K241438.

When was Signus Tetris St; Signus Tetris R St approved by the FDA?

Signus Tetris St; Signus Tetris R St received FDA 510(k) clearance on 2024-09-11, under approval number K241438.

What company makes Signus Tetris St; Signus Tetris R St?

Signus Tetris St; Signus Tetris R St is manufactured by Signus Medizintechnik GmbH.

What is the FDA product code for Signus Tetris St; Signus Tetris R St?

The FDA product code for Signus Tetris St; Signus Tetris R St is MAX.

Other Devices by Signus Medizintechnik GmbH

K151704Diplomat® Spinal System K220658COSY Cervicothoracic Occipital Rod-Screw System K212755SIGNUS SACRONAIL® Transsacral Stabilization System K243188CYLOX® ST

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

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