Medical Device Manufacturer · US , Atlanta , GA

Meditech Spine, LLC - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2015

Recent clearances: Cure 2.0 Anterior Cervical Plate (ACP) System, Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System, Cure™ Lumbar Plate System

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Meditech Spine, LLC Orthopedic ✕

10 devices

1-10 of 10

Cleared Mar 18, 2021

Cure 2.0 Anterior Cervical Plate (ACP) System

Orthopedic · 44d

Cleared Sep 11, 2020

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

Orthopedic · 98d

Cleared May 12, 2020

Cure™ Lumbar Plate System

Orthopedic · 14d

Cleared Aug 31, 2018

Cure™ OPEL-C Plate System

Orthopedic · 80d

Cleared Apr 23, 2018

Cure™ Lumbar Plate System

Orthopedic · 101d

Cleared Jun 16, 2017

Cure™ Lumbar Plate System

Orthopedic · 21d

Cleared Jun 02, 2017

Talos® Lumbar (HA) PEEK IBF Devices

Orthopedic · 114d

Cleared Jul 01, 2016

Cure™ Anterior Cervical Plate (ACP) System

Orthopedic · 121d

Cleared Oct 14, 2015

Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral...

Orthopedic · 203d

Cleared Feb 22, 2015

Talos-C(HA) Cervical Intervertebral Body Fusion Devices

Orthopedic · 184d