FDA applicant

Kalitec Direct, LLC

Orlando, FL9 decisions2011–20180 recalls

FDA records 9 decisions for Kalitec Direct, LLC (Orlando, FL) from 2011 to 2018: 9 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 3 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 Kalitec Direct, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011high 4 (2017) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Kalitec Direct, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Kalitec”

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

Kalitec Medical, LLC 3 Kalitec Direct, LLC Doing Business AS Kalitec Medical 1

Kalitec Direct, 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 “Kalitec”