Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

IntraOp Alignment System; CONTOUR3D Bending System

N.º K: K253216 · 2026-06-25

SolicitanteAlphatec Spine, Inc.
Fecha de decisión2026-06-25
Código de productoSIN
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

IntraOp Alignment System; CONTOUR3D Bending System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253216. The device is classified under product code SIN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IntraOp Alignment System; CONTOUR3D Bending System?

IntraOp Alignment System; CONTOUR3D Bending System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K253216.

When did IntraOp Alignment System; CONTOUR3D Bending System receive FDA 510(k) clearance?

IntraOp Alignment System; CONTOUR3D Bending System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253216.

Who is the listed applicant for IntraOp Alignment System; CONTOUR3D Bending System?

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

What is the FDA product code for IntraOp Alignment System; CONTOUR3D Bending System?

The FDA product code for IntraOp Alignment System; CONTOUR3D Bending System is SIN.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Alphatec Spine, Inc. como solicitante

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.

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)K251080IdentiTi II Cervical Interbody System

Ver todos los 61 dispositivos →

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.

↑