FDA 510(k)

M6-C Artificial Cervical Disc Instruments AS

N.º K: K220861 · 2022-06-02

Fecha de decisión2022-06-02

Código de productoQLQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

M6-C Artificial Cervical Disc Instruments AS is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220861. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the M6-C Artificial Cervical Disc Instruments AS?

M6-C Artificial Cervical Disc Instruments AS is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Spinal Kinetics, LLC. The 510(k) number is K220861.

When did M6-C Artificial Cervical Disc Instruments AS receive FDA 510(k) clearance?

M6-C Artificial Cervical Disc Instruments AS received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220861.

Who is the listed applicant for M6-C Artificial Cervical Disc Instruments AS?

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

What is the FDA product code for M6-C Artificial Cervical Disc Instruments AS?

The FDA product code for M6-C Artificial Cervical Disc Instruments AS is QLQ.

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

Dispositivos relacionados (Código: QLQ)

K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.K250554prodisc® L InstrumentsCentinel Spine, LLC K242869prodisc® L InstrumentsCentinel Spine, LLC K241117M6-C™ Instrumentación de Uso Único, DesechableSpinal Kinetics / Orthofix / Seaspine K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC

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.