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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Meditech Spine, LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

101 daysmedian FDA review time
203 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC2021-03-18440
K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-Meditech Spine, LLC2020-09-11980
K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC2020-05-12140
K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC2018-08-31800
K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC2018-04-231010
K171538Cure™ Lumbar Plate SystemMeditech Spine, LLC2017-06-16210
K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC2017-06-021140
K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC2016-07-011210
K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Meditech Spine, LLC2015-10-142030
K142345Talos-C(HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC2015-02-221840

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda