FDA 510(k)

Tyber Medical BioTy® Nanotopography Trauma Screw

Número K: K161597 · 2016-11-16

Data da decisão2016-11-16

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tyber Medical BioTy® Nanotopography Trauma Screw is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K161597. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tyber Medical BioTy® Nanotopography Trauma Screw?

Tyber Medical BioTy® Nanotopography Trauma Screw is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Tyber Medical, LLC. The 510(k) number is K161597.

When did Tyber Medical BioTy® Nanotopography Trauma Screw receive FDA 510(k) clearance?

Tyber Medical BioTy® Nanotopography Trauma Screw received FDA 510(k) clearance on 2016-11-16, under 510(k) number K161597.

Who is the listed applicant for Tyber Medical BioTy® Nanotopography Trauma Screw?

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

What is the FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw?

The FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw is HWC. This falls under the Cardiovascular category.

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 Tyber Medical, LLC como candidato(a)

K261207Exalta Proximal Tibia Plating System K260810Anteralign LS coverplate K261060Navigated LLIF Impactable Tracker K253042Tyber Medical Trauma Screw K252901Tyber Medical Trauma Screw K252742Navigated Instruments

Ver todos os 27 dispositivos →

Dispositivos Relacionados (Código: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

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.