FDA applicant

Meditech Spine, LLC

Atlanta, GA10 decisions2015–20210 recalls

FDA records 10 decisions for Meditech Spine, LLC (Atlanta, GA) from 2015 to 2021: 10 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Meditech Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015high 2 (2015) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Meditech Spine, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meditech Spine, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Meditech”

FDA records each applicant name separately; these may or may not be the same firm.

Meditech International, Inc. 5 Meditech, Inc. 3 Meditech Gloves Sdn Bhd 2 Meditech Kft. 2 Meditech Advisors, LLC 2 Meditech Endoscopy, Ltd. 1

Meditech Spine, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Meditech”