510(k) Report

FDA applicant

Sagico VA USA, LLC

Tampa, FL3 decisions2023–20230 recalls

FDA records 3 decisions for Sagico VA USA, LLC (Tampa, FL) in 2023: 3 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 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 Sagico VA USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2023: 3
2023high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Sagico VA USA, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sagico VA USA, 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?

  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 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.

  • K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 20231cites it

What has FDA decided for it lately?

  • K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC · 2023
  • K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 2023
  • K223143SAGICO Spinal SystemSagico VA USA, LLC · 2023

All 3 as Sagico VA USA, LLC →