FDA 510(k)

2.1 x 255mm Drilo, 22mm Stop

N.º K: K223199 · 2022-11-15

Fecha de decisión2022-11-15

Código de productoHBE

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

2.1 x 255mm Drill, 22mm Stop is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K223199. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 2.1 x 255mm Drill, 22mm Stop?

2.1 x 255mm Drill, 22mm Stop is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Biomet Microfixation. The 510(k) number is K223199.

When did 2.1 x 255mm Drill, 22mm Stop receive FDA 510(k) clearance?

2.1 x 255mm Drill, 22mm Stop received FDA 510(k) clearance on 2022-11-15, under 510(k) number K223199.

Who is the listed applicant for 2.1 x 255mm Drill, 22mm Stop?

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

What is the FDA product code for 2.1 x 255mm Drill, 22mm Stop?

The FDA product code for 2.1 x 255mm Drill, 22mm Stop is HBE.

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

Otros registros que enlistan a Biomet Microfixation como solicitante

K261002Pectus Blu System K241709Pectus Blu Support Bar System K212782SternaLock Sternal Closure System K212608RibFix Blu Thoracic Fixation System K213712Pectus Support Bar System K213208Twist Drills

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: HBE)

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.