FDA 510(k)

Pitkar Spinal Pedicle Screw System

Número K: K240233 · 2024-09-09

RequerenteS.H.Pitkar Orthotools Pvt. , Ltd.

Data da decisão2024-09-09

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pitkar Spinal Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K240233. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pitkar Spinal Pedicle Screw System?

Pitkar Spinal Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is S.H.Pitkar Orthotools Pvt. , Ltd.. The 510(k) number is K240233.

When did Pitkar Spinal Pedicle Screw System receive FDA 510(k) clearance?

Pitkar Spinal Pedicle Screw System received FDA 510(k) clearance on 2024-09-09, under 510(k) number K240233.

Who is the listed applicant for Pitkar Spinal Pedicle Screw System?

The FDA 510(k) record lists S.H.Pitkar Orthotools Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pitkar Spinal Pedicle Screw System?

The FDA product code for Pitkar Spinal Pedicle Screw System is NKB.

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 S.H.Pitkar Orthotools Pvt. , Ltd. como candidato(a)

K200728Pitkar DeftFix System K200518Pitkar External Fixation System - Rail Mechanism K192619Pitkar Locked Plating System K190486Pitkar External Fixation System

Dispositivos Relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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.