FDA 510(k)

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

Número K: K201506 · 2020-09-11

Data da decisão2020-09-11

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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