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FDA 510(k)

LATERAL Spine Truss System

K-Number: K153436 · 2016-06-06

Applicant4Web, Inc.
Decision Date2016-06-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATERAL Spine Truss System is a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2016-06-06 under approval number K153436. 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?

LATERAL Spine Truss System is a medical device that received FDA 510(k) clearance on 2016-06-06. It is manufactured by 4Web, Inc.. The 510(k) number is K153436.

When was LATERAL Spine Truss System approved by the FDA?

LATERAL Spine Truss System received FDA 510(k) clearance on 2016-06-06, under approval number K153436.

What company makes LATERAL Spine Truss System?

LATERAL Spine Truss System is manufactured by 4Web, Inc..

What is the FDA product code for LATERAL Spine Truss System?

The FDA product code for LATERAL Spine Truss System is MAX.

Related Clinical Trials

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Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by 4Web, Inc.

K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device 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)

View all 11 devices →

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.

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