FDA 510(k)

EVOLUTION SPINE Interbody System

Número K: K223146 · 2023-02-07

Data da decisão2023-02-07

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOLUTION SPINE Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2023-02-07 under 510(k) number K223146. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOLUTION SPINE Interbody System?

EVOLUTION SPINE Interbody System is a medical device that received FDA 510(k) clearance on 2023-02-07. The listed applicant is Evolution Spine. The 510(k) number is K223146.

When did EVOLUTION SPINE Interbody System receive FDA 510(k) clearance?

EVOLUTION SPINE Interbody System received FDA 510(k) clearance on 2023-02-07, under 510(k) number K223146.

Who is the listed applicant for EVOLUTION SPINE Interbody System?

The FDA 510(k) record lists Evolution Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOLUTION SPINE Interbody System?

The FDA product code for EVOLUTION SPINE Interbody System is OVD.

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Outros registros que listam Evolution Spine como candidato(a)

K262094E3D™-C Interbody System K260038E3D™-C Interbody System K250167Evolution Spine Navigation Instruments K241846E3D™-C Interbody System K240368E3D™-A Interbody System K232432E3D™-A Interbody System

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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