FDA 510(k)

aprevo® cervical interbody system

Número K: K252894 · 2026-01-06

Data da decisão2026-01-06

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

aprevo® cervical interbody system is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K252894. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the aprevo® cervical interbody system?

aprevo® cervical interbody system is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Carlsmed, Inc.. The 510(k) number is K252894.

When did aprevo® cervical interbody system receive FDA 510(k) clearance?

aprevo® cervical interbody system received FDA 510(k) clearance on 2026-01-06, under 510(k) number K252894.

Who is the listed applicant for aprevo® cervical interbody system?

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

What is the FDA product code for aprevo® cervical interbody system?

The FDA product code for aprevo® cervical interbody system is ODP.

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Outros registros que listam Carlsmed, Inc. como candidato(a)

K262149corra® cervical plating system K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system K260570corra™ cervical plating system K252611aprevo® cervical plating system K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams K250987aprevo® posterior/transforaminal lumbar interbody fusion device

Ver todos os 22 dispositivos →

Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fonte oficial

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