FDA 510(k)

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System

Número K: K221050 · 2022-06-30

Data da decisão2022-06-30

Código do produtoOUR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K221050. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System?

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K221050.

When did ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System receive FDA 510(k) clearance?

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System received FDA 510(k) clearance on 2022-06-30, under 510(k) number K221050.

Who is the listed applicant for ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System?

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

What is the FDA product code for ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System?

The FDA product code for ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System is OUR.

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 Aegis Spine, Inc. como candidato(a)

K223521ZESPIN SI Joint Fusion System K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System K221719ABTross ALIF Prateleira Expandível Sistema K203531XYPAN Expandable Lumbar Cage System

Dispositivos Relacionados (Código: OUR)

K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web Medical K251365OptumSI Implant SystemSi Solutions, LLC

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.