FDA 510(k)

Vertera Spine Cohere Cervical Interbody Fusion Device

K-Number: K173030 · 2017-11-21

Decision Date2017-11-21

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vertera Spine Cohere Cervical Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K173030. 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 Vertera Spine Cohere Cervical Interbody Fusion Device?

Vertera Spine Cohere Cervical Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K173030.

When did Vertera Spine Cohere Cervical Interbody Fusion Device receive FDA 510(k) clearance?

Vertera Spine Cohere Cervical Interbody Fusion Device received FDA 510(k) clearance on 2017-11-21, under 510(k) number K173030.

Who is the listed applicant for Vertera Spine Cohere Cervical Interbody Fusion Device?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vertera Spine Cohere Cervical Interbody Fusion Device?

The FDA product code for Vertera Spine Cohere Cervical 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 Nu Vasive, Incorporated as applicant

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System K230894NuVasive Modulus ALIF System K230989Rod Registration Frame K223181NuVasive Reline System K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.