FDA 510(k)

aprevo® posterior/transforaminal lumbar interbody fusion device

Número K: K250987 · 2025-06-30

Data da decisão2025-06-30

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

aprevo® posterior/transforaminal lumbar interbody fusion device is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K250987. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the aprevo® posterior/transforaminal lumbar interbody fusion device?

aprevo® posterior/transforaminal lumbar interbody fusion device is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Carlsmed, Inc.. The 510(k) number is K250987.

When did aprevo® posterior/transforaminal lumbar interbody fusion device receive FDA 510(k) clearance?

aprevo® posterior/transforaminal lumbar interbody fusion device received FDA 510(k) clearance on 2025-06-30, under 510(k) number K250987.

Who is the listed applicant for aprevo® posterior/transforaminal lumbar interbody fusion device?

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® posterior/transforaminal lumbar interbody fusion device?

The FDA product code for aprevo® posterior/transforaminal lumbar interbody fusion device is MAX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K252894aprevo® cervical interbody 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

Ver todos os 22 dispositivos →

Dispositivos Relacionados (Código: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.