FDA 510(k)

Mikron Spinal Fixation System

Número K: K171497 · 2017-10-12

RequerenteMikron Makina Sanayi Ticaret Co. , Ltd.

Data da decisão2017-10-12

Código do produtoMNI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mikron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171497. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mikron Spinal Fixation System?

Mikron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. The 510(k) number is K171497.

When did Mikron Spinal Fixation System receive FDA 510(k) clearance?

Mikron Spinal Fixation System received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171497.

Who is the listed applicant for Mikron Spinal Fixation System?

The FDA 510(k) record lists Mikron Makina Sanayi Ticaret Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mikron Spinal Fixation System?

The FDA product code for Mikron Spinal Fixation System is MNI.

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: MNI)

K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.K160003Sniper (R) Spine SystemSpine Wave, 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.