FDA 510(k)

Lateral Spine Truss System (LSTS) Interbody Fusion Device

K-Number: K211388 · 2021-08-05

Decision Date2021-08-05

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Lateral Spine Truss System (LSTS) Interbody Fusion Device is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under approval number K211388. 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 Lateral Spine Truss System (LSTS) Interbody Fusion Device?

Lateral Spine Truss System (LSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K211388.

When was Lateral Spine Truss System (LSTS) Interbody Fusion Device approved by the FDA?

Lateral Spine Truss System (LSTS) Interbody Fusion Device received FDA 510(k) clearance on 2021-08-05, under approval number K211388.

What company makes Lateral Spine Truss System (LSTS) Interbody Fusion Device?

Lateral Spine Truss System (LSTS) Interbody Fusion Device is manufactured by 4Web Medical, Inc..

What is the FDA product code for Lateral Spine Truss System (LSTS) Interbody Fusion Device?

The FDA product code for Lateral Spine Truss System (LSTS) Interbody Fusion Device is MAX.

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Related PubMed Literature

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Other Devices by 4Web Medical, Inc.

K221283Hammertoe Truss System (HTS) K220463Osteotomy Truss System (OTS) K212527Cervical Spine Truss System Plating Solution (CSTS-PS) K231739Cervical Spine Truss System (CSTS) K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device

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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.