FDA 510(k)

Tecomet Global Unite Short Stem Instrumentation

N.º K: K211553 · 2021-08-04

SolicitanteSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

Fecha de decisión2021-08-04

Código de productoPHX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tecomet Global Unite Short Stem Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211553. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tecomet Global Unite Short Stem Instrumentation?

Tecomet Global Unite Short Stem Instrumentation is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.. The 510(k) number is K211553.

When did Tecomet Global Unite Short Stem Instrumentation receive FDA 510(k) clearance?

Tecomet Global Unite Short Stem Instrumentation received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211553.

Who is the listed applicant for Tecomet Global Unite Short Stem Instrumentation?

The FDA 510(k) record lists Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tecomet Global Unite Short Stem Instrumentation?

The FDA product code for Tecomet Global Unite Short Stem Instrumentation is PHX.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 NCT07095751Sistema de Evaluación de Catéter Uro-Cam Asistido por Inteligencia Artificial para el Diagnóstico de Cáncer de VésículaNOT_YET_RECRUITING

Dispositivos relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Sistema de Instrumento Desviado del EjeZimmer, Inc.K260102Tornier Perform Reversa Glénoide y Tornier Perform Reversa Glénoide Aumentada del Hombro SistemaStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Dispositivo de Hombro Retroflexible - Base Placas de Glenosphere de HABiomet Orthopedics

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.