FDA 510(k)

Solanas® Posterior OCT Fixation System

N.º K: K191185 · 2019-06-03

Fecha de decisión2019-06-03

Código de productoNKG

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Solanas® Posterior OCT Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2019-06-03 under 510(k) number K191185. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Solanas® Posterior OCT Fixation System?

Solanas® Posterior OCT Fixation System is a medical device that received FDA 510(k) clearance on 2019-06-03. The listed applicant is Alphatec Spine. The 510(k) number is K191185.

When did Solanas® Posterior OCT Fixation System receive FDA 510(k) clearance?

Solanas® Posterior OCT Fixation System received FDA 510(k) clearance on 2019-06-03, under 510(k) number K191185.

Who is the listed applicant for Solanas® Posterior OCT Fixation System?

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

What is the FDA product code for Solanas® Posterior OCT Fixation System?

The FDA product code for Solanas® Posterior OCT Fixation System is NKG.

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 Alphatec Spine como solicitante

K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer K240951Invictus Robotic Navigation Instruments K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System K160958Battalion Universal Spacer System

Dispositivos relacionados (Código: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

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.