510(k) Report

FDA applicant

Advanced Research Medical, LLC

Burnsville, MN2 decisions2018–20211 recall

FDA records 2 decisions for Advanced Research Medical, LLC (Burnsville, MN) from 2018 to 2021: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OUR (Sacroiliac Joint Fixation). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Advanced Research Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2018high 1 (2023) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Advanced Research Medical, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • OURSacroiliac Joint Fixation1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC · 2021
  • K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 20181 recall

All 2 as Advanced Research Medical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K173947ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop…Mar 14, 2023Class II