FDA 510(k)

ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System

Número K: K170821 · 2017-06-08

Data da decisão2017-06-08

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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 Choicespine, LP como candidato(a)

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 os 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.

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.