FDA 510(k)

My3D® Personalized Pelvic Reconstruction

Número K: K223348 · 2023-01-30

Data da decisão2023-01-30

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

My3D® Personalized Pelvic Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K223348. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K223348.

When did My3D® Personalized Pelvic Reconstruction receive FDA 510(k) clearance?

My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2023-01-30, under 510(k) number K223348.

Who is the listed applicant for My3D® Personalized Pelvic Reconstruction?

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

What is the FDA product code for My3D® Personalized Pelvic Reconstruction?

The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.

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 Onkos Surgical, Inc. como candidato(a)

K253066ELEOS™ with NanoCept® Technology Limb Salvage System K252920ELEOS™ Limb Salvage System with NanoCept® Technology K180130ELEOS™ Bipolar Acetabular System K161520ELEOS Limb Salvage System

Dispositivos Relacionados (Código: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, 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.