FDA 510(k)

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

Número K: K200792 · 2020-10-05

Data da decisão2020-10-05

Código do produtoPQC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K200792. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Medacta Inernational SA. The 510(k) number is K200792.

When did MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides receive FDA 510(k) clearance?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides received FDA 510(k) clearance on 2020-10-05, under 510(k) number K200792.

Who is the listed applicant for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

The FDA 510(k) record lists Medacta Inernational SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

The FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is PQC.

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 Medacta Inernational SA como candidato(a)

K200551MectaLIF Transforaminal TiPEEK K193175Lateralized Glenosphere K193559NextAR TKA Platform

Dispositivos Relacionados (Código: PQC)

K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical K231483MySpine Unilateral GuidesMedacta International S.A.K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.

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.