FDA 510(k)

Lateral Spinal Truss System (LSTS) Interbody Fusion Device

K-Number: K172392 · 2017-11-07

Decision Date2017-11-07

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Lateral Spinal Truss System (LSTS) Interbody Fusion Device is a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2017-11-07 under approval number K172392. 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 Spinal Truss System (LSTS) Interbody Fusion Device?

Lateral Spinal Truss System (LSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by 4Web, Inc.. The 510(k) number is K172392.

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

Lateral Spinal Truss System (LSTS) Interbody Fusion Device received FDA 510(k) clearance on 2017-11-07, under approval number K172392.

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

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

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

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

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Other Devices by 4Web, Inc.

K153436LATERAL Spine Truss System K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device K170851Anterior Spine Truss System (STS) Interbody Fusion Device K172294Osteotomy Truss System (OTS) K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)

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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

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