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FDA 510(k)

NuVasive® Interfixated Interbody System

K-Number: K160051 · 2016-04-20

ApplicantNu Vasive, Incorporated
Decision Date2016-04-20
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® Interfixated Interbody 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 2016-04-20 under 510(k) number K160051. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive® Interfixated Interbody System?

NuVasive® Interfixated Interbody System is a medical device that received FDA 510(k) clearance on 2016-04-20. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K160051.

When did NuVasive® Interfixated Interbody System receive FDA 510(k) clearance?

NuVasive® Interfixated Interbody System received FDA 510(k) clearance on 2016-04-20, under 510(k) number K160051.

Who is the listed applicant for NuVasive® Interfixated Interbody 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® Interfixated Interbody System?

The FDA product code for NuVasive® Interfixated Interbody System is OVD.

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: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

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