FDA 510(k)

Cervical Spine Truss System (CSTS) Interbody Fusion Device

K-Number: K221266 · 2023-01-05

Decision Date2023-01-05

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cervical Spine Truss System (CSTS) Interbody Fusion Device is a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-01-05 under approval number K221266. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Spine Truss System (CSTS) Interbody Fusion Device?

Cervical Spine Truss System (CSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2023-01-05. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K221266.

When was Cervical Spine Truss System (CSTS) Interbody Fusion Device approved by the FDA?

Cervical Spine Truss System (CSTS) Interbody Fusion Device received FDA 510(k) clearance on 2023-01-05, under approval number K221266.

What company makes Cervical Spine Truss System (CSTS) Interbody Fusion Device?

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

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

The FDA product code for Cervical Spine Truss System (CSTS) Interbody Fusion Device is ODP.

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Other Devices by 4Web Medical, Inc.

K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device 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

View all 11 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.