FDA 510(k)

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

N.º K: K201506 · 2020-09-11

Fecha de decisión2020-09-11

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Spine, LLC. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201506. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Meditech Spine, LLC. The 510(k) number is K201506.

When did Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System receive FDA 510(k) clearance?

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201506.

Who is the listed applicant for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

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

What is the FDA product code for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

The FDA product code for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is ODP.

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Otros registros que enlistan a Meditech Spine, LLC como solicitante

K210286Cure 2.0 Anterior Cervical Plate (ACP) System K201136Cure™ Lumbar Plate System K181543Cure™ OPEL-C Plate System K180090Cure™ Lumbar Plate System K171538Cure™ Lumbar Plate System K170395Talos® Lumbar (HA) PEEK IBF Devices

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Dispositivos relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fuente oficial

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