FDA 510(k)

ZipE Knotless Tissue Repair and Attachment Devices

Número K: K162429 · 2017-03-13

Data da decisão2017-03-13

Código do produtoMAI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZipE Knotless Tissue Repair and Attachment Devices is the device name listed in this FDA 510(k) record. The listed applicant is Ziptek, LLC. It received FDA 510(k) clearance on 2017-03-13 under 510(k) number K162429. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZipE Knotless Tissue Repair and Attachment Devices?

ZipE Knotless Tissue Repair and Attachment Devices is a medical device that received FDA 510(k) clearance on 2017-03-13. The listed applicant is Ziptek, LLC. The 510(k) number is K162429.

When did ZipE Knotless Tissue Repair and Attachment Devices receive FDA 510(k) clearance?

ZipE Knotless Tissue Repair and Attachment Devices received FDA 510(k) clearance on 2017-03-13, under 510(k) number K162429.

Who is the listed applicant for ZipE Knotless Tissue Repair and Attachment Devices?

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

What is the FDA product code for ZipE Knotless Tissue Repair and Attachment Devices?

The FDA product code for ZipE Knotless Tissue Repair and Attachment Devices is MAI.

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: MAI)

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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.