FDA 510(k)

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

Número K: K230808 · 2023-04-21

RequerenteKyocera Medical Technologies, Inc.

Data da decisão2023-04-21

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K230808. 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 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K230808.

When did PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System receive FDA 510(k) clearance?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230808.

Who is the listed applicant for PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA product code for PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is OVD.

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Outros registros que listam Kyocera Medical Technologies, Inc. como candidato(a)

K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System K242928Tesera-k SC System K242045Initia T3 Acetabular Hemispherical Shell System K242771Tesera-k PL System and Tesera-k XL System K243295Initia Knee System K243015Skyway Anterior Cervical Plate 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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