FDA 510(k)

NuVasive Cohere ALIF System Intervertebral Body Fusion Device

Numéro K : K221751 · 2022-10-21

Date de décision2022-10-21

Code produitOVD

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

NuVasive Cohere ALIF System Intervertebral Body 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 2022-10-21 under 510(k) number K221751. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NuVasive Cohere ALIF System Intervertebral Body Fusion Device?

NuVasive Cohere ALIF System Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K221751.

When did NuVasive Cohere ALIF System Intervertebral Body Fusion Device receive FDA 510(k) clearance?

NuVasive Cohere ALIF System Intervertebral Body Fusion Device received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221751.

Who is the listed applicant for NuVasive Cohere ALIF System Intervertebral Body 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 NuVasive Cohere ALIF System Intervertebral Body Fusion Device?

The FDA product code for NuVasive Cohere ALIF System Intervertebral Body Fusion Device is OVD.

Essais cliniques associés

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Autres dossiers indiquant Nu Vasive, Incorporated en tant que demandeur

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 K221388NuVasive Reline Cervical System K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System

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Dispositifs connexes (Code : OVD)

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis K261408SABER-XA SystemElevation Spine K261809Interwedge® Standalone LateralFoundation Surgical Group K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Source officielle

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