FDA 510(k)

“BioGend” Interbody Fusion System 001 Cage

Número K: K233075 · 2024-03-06

RequerenteBiogend Therapeutics Co., Ltd.

Data da decisão2024-03-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

“BioGend” Interbody Fusion System 001 Cage is the device name listed in this FDA 510(k) record. The listed applicant is Biogend Therapeutics Co., Ltd.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233075. 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 “BioGend” Interbody Fusion System 001 Cage?

“BioGend” Interbody Fusion System 001 Cage is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Biogend Therapeutics Co., Ltd.. The 510(k) number is K233075.

When did “BioGend” Interbody Fusion System 001 Cage receive FDA 510(k) clearance?

“BioGend” Interbody Fusion System 001 Cage received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233075.

Who is the listed applicant for “BioGend” Interbody Fusion System 001 Cage?

The FDA 510(k) record lists Biogend Therapeutics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “BioGend” Interbody Fusion System 001 Cage?

The FDA product code for “BioGend” Interbody Fusion System 001 Cage 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

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.