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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) 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. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K211388.

When did Lateral Spine Truss System (LSTS) Interbody Fusion Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Lateral Spine Truss System (LSTS) Interbody Fusion Device?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

Other records listing 4Web Medical, Inc. as applicant

K252834Sacroiliac Joint Truss System (SJTS)K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K251117Cervical Spine Truss System (CSTS)K240388Osteotomy Truss System (OTS)K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)

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Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.