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FDA 510(k)

NuVasive CoRoent Small Interlock II System

K-Number: K170961 · 2017-06-08

ApplicantNu Vasive, Incorporated
Decision Date2017-06-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive CoRoent Small Interlock II System 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 2017-06-08 under 510(k) number K170961. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive CoRoent Small Interlock II System?

NuVasive CoRoent Small Interlock II System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K170961.

When did NuVasive CoRoent Small Interlock II System receive FDA 510(k) clearance?

NuVasive CoRoent Small Interlock II System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170961.

Who is the listed applicant for NuVasive CoRoent Small Interlock II System?

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 NuVasive CoRoent Small Interlock II System?

The FDA product code for NuVasive CoRoent Small Interlock II System is OVE.

Other records listing Nu Vasive, Incorporated as applicant

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.

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 SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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