FDA 510(k)

ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System

N.º K: K170821 · 2017-06-08

Fecha de decisión2017-06-08

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170821. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System?

ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Choicespine, LP. The 510(k) number is K170821.

When did ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System receive FDA 510(k) clearance?

ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170821.

Who is the listed applicant for ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System?

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

What is the FDA product code for ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System?

The FDA product code for ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System is NKB.

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 Choicespine, LP como solicitante

K190227Boomerang™ Anterior Cervical Plate System K183397ChoiceSpine Stealth Cervical Spacer System K182721Choice Spine Navigation System K183214Raven Lumbar Plate System K180519HARRIER-SA™ Lumbar Interbody System K172816TiGer Shark™ System

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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.