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 the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-01-05 under 510(k) 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. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K221266.

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

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

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

The FDA product code for Cervical Spine 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 NCT04388332ACDF Using Structural Allograft vs. Tritanium CRECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_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)

View all 13 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.