510(k) Report

FDA applicant

Met One Technologies, LLC

El Paso, TX7 decisions2017–20260 recalls

FDA records 7 decisions for Met One Technologies, LLC (El Paso, TX) from 2017 to 2026: 7 510(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 110 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Met One Technologies”.

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 Met One Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12018: 12020: 12022: 12023: 12025: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Met One Technologies, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Met One Technologies, 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
  • HRSPlate, Fixation, Bone1decision
  • NKGPosterior Cervical Screw System1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 110 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 27 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies · 20171cites it
  • K193457AUDERE Lumbar Spacer SystemMet One Technologies · 20201cites it
  • K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC · 20251cites it
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 20221cites it

What has FDA decided for it lately?

  • K251732Wrist Fracture SystemMet One Technologies, LLC · 2026
  • K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
  • K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
  • K193457AUDERE Lumbar Spacer SystemMet One Technologies · 2020
  • K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies · 2018
  • K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies · 2017

All 4 as Met One Technologies, LLC →All 3 as Met One Technologies →