FDA 510(k)

DualX

K-Number: K211740 · 2021-09-29

Decision Date2021-09-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DualX is a medical device manufactured by Amplify Surgical, Inc.. It received FDA 510(k) clearance on 2021-09-29 under approval number K211740. 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 DualX?

DualX is a medical device that received FDA 510(k) clearance on 2021-09-29. It is manufactured by Amplify Surgical, Inc.. The 510(k) number is K211740.

When was DualX approved by the FDA?

DualX received FDA 510(k) clearance on 2021-09-29, under approval number K211740.

What company makes DualX?

DualX is manufactured by Amplify Surgical, Inc..

What is the FDA product code for DualX?

The FDA product code for DualX is MAX.

Other Devices by Amplify Surgical, Inc.

K192434DualX Lumbar Intervertebral Body Fusion Device K222203DualXSLIM(R) T/PLIF

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

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