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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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2016-06-06 under 510(k) 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. The listed applicant is 4Web, Inc.. The 510(k) number is K153436.

When did LATERAL Spine Truss System receive FDA 510(k) clearance?

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

Who is the listed applicant for LATERAL Spine Truss System?

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

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

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

Other records listing 4Web, Inc. as applicant

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.

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceK190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

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Related Devices (Code: MAX)

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.

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 CorporationK253151Fule 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.

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