510(k) Report

FDA applicant

International Advanced Medical Enterprises, Inc.

Pleasant Hill, CA1 decision2000–20000 recalls

FDA records 1 decision for International Advanced Medical Enterprises, Inc. (Pleasant Hill, CA) in 2000: 1 510(k) clearance. All are in product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 1 predicate, 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 International Advanced Medical Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Advanced Medical Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — International Advanced Medical Enterprises, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 20006cite it

What has FDA decided for it lately?

  • K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000

The one decision as International Advanced Medical Enterprises, Inc. →