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)

LimiFlex® Dynamic Sagittal Tether Instrument Set

N.º K: K253374 · 2026-06-16

SolicitanteEmpirical Spine
Fecha de decisión2026-06-16
Código de productoSGL
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

LimiFlex® Dynamic Sagittal Tether Instrument Set is the device name listed in this FDA 510(k) record. The listed applicant is Empirical Spine. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253374. The device is classified under product code SGL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LimiFlex® Dynamic Sagittal Tether Instrument Set?

LimiFlex® Dynamic Sagittal Tether Instrument Set is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Empirical Spine. The 510(k) number is K253374.

When did LimiFlex® Dynamic Sagittal Tether Instrument Set receive FDA 510(k) clearance?

LimiFlex® Dynamic Sagittal Tether Instrument Set received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253374.

Who is the listed applicant for LimiFlex® Dynamic Sagittal Tether Instrument Set?

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

What is the FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set?

The FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set is SGL.

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

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.

↑