510(k) Report

FDA applicant

Kalitec Medical, LLC

Orlando, FL3 decisions2019–20230 recalls

FDA records 3 decisions for Kalitec Medical, LLC (Orlando, FL) from 2019 to 2023: 3 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kalitec Medical”.

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 Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12022: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Kalitec Medical, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kalitec Medical, 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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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 145 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 20191cites it

What has FDA decided for it lately?

  • K230974NIDO™ Pedicle Screw SystemKalitec Medical · 2023
  • K220902Navagio Lumbar CageKalitec Medical, LLC · 2022
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019

All 2 as Kalitec Medical, LLC →The one decision as Kalitec Medical →

Other applicant names beginning “Kalitec”

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

Kalitec Direct, LLC 9Kalitec Direct, LLC Doing Business AS Kalitec Medical 1