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FDA 510(k)

Vertera Spine Cohere Cervical Interbody Fusion Device

K-Number: K173030 · 2017-11-21

ApplicantNu Vasive, Incorporated
Decision Date2017-11-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vertera Spine Cohere Cervical Interbody Fusion Device is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-11-21 under approval 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. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K173030.

When was Vertera Spine Cohere Cervical Interbody Fusion Device approved by the FDA?

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

What company makes Vertera Spine Cohere Cervical Interbody Fusion Device?

Vertera Spine Cohere Cervical Interbody Fusion Device is manufactured by Nu Vasive, Incorporated.

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023)

Other Devices by Nu Vasive, Incorporated

K162138NuVasive CoRoent Small Ti-C System K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock™ System K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie System K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System

View all 79 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

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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