Meditech Spine, LLC

FDA Regulatory Profile

Meditech Spine, LLC has 0 FDA recalls, 1 inspection, 10 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 26, 2019 · NAI
Latest 510(k)
Mar 18, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 26, 2019Atlanta, GADevicesNo Action Indicated (NAI)3009405289

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMar 18, 2021
K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body…Sep 11, 2020
K201136Cure™ Lumbar Plate SystemMay 12, 2020
K181543Cure™ OPEL-C Plate SystemAug 31, 2018
K180090Cure™ Lumbar Plate SystemApr 23, 2018
K171538Cure™ Lumbar Plate SystemJun 16, 2017
K170395Talos® Lumbar (HA) PEEK IBF DevicesJun 2, 2017
K160604Cure™ Anterior Cervical Plate (ACP) SystemJul 1, 2016
K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices…Oct 14, 2015
K142345Talos-C(HA) Cervical Intervertebral Body Fusion DevicesFeb 22, 2015