FDA 510(k)

Cervical Spinal Truss System (CSTS) Interbody Fusion Device

K-Number: K173159 · 2018-01-08

Decision Date2018-01-08

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K173159. 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 Spinal Truss System (CSTS) Interbody Fusion Device?

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is 4Web, Inc.. The 510(k) number is K173159.

When did Cervical Spinal Truss System (CSTS) Interbody Fusion Device receive FDA 510(k) clearance?

Cervical Spinal Truss System (CSTS) Interbody Fusion Device received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173159.

Who is the listed applicant for Cervical Spinal Truss System (CSTS) Interbody Fusion Device?

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 Cervical Spinal Truss System (CSTS) Interbody Fusion Device?

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

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 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 NCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITING

Other records listing 4Web, Inc. as applicant

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 Device K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

View all 11 devices →

Related Devices (Code: ODP)

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.