FDA 510(k)

Delphos Implants Rigid Fixation System

N.º K: K182609 · 2019-03-29

SolicitanteDelphos Implants - Ind.Com. Importacao E Exportacao DE

Fecha de decisión2019-03-29

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Delphos Implants Rigid Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Delphos Implants - Ind.Com. Importacao E Exportacao DE. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K182609. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Delphos Implants Rigid Fixation System?

Delphos Implants Rigid Fixation System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Delphos Implants - Ind.Com. Importacao E Exportacao DE. The 510(k) number is K182609.

When did Delphos Implants Rigid Fixation System receive FDA 510(k) clearance?

Delphos Implants Rigid Fixation System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182609.

Who is the listed applicant for Delphos Implants Rigid Fixation System?

The FDA 510(k) record lists Delphos Implants - Ind.Com. Importacao E Exportacao DE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delphos Implants Rigid Fixation System?

The FDA product code for Delphos Implants Rigid Fixation System is JEY.

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 NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: JEY)

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical Corporation K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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.