510(k) Report

FDA applicant

Karen E. Warden, M.E.B.E.

Cleveland, OH1 decision1998–19980 recalls

FDA records 1 decision for Karen E. Warden, M.E.B.E. (Cleveland, OH) in 1998: 1 510(k) clearance. All are in product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). 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 Karen E. Warden, M.E.B.E.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karen E. Warden, M.E.B.E. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karen E. Warden, M.E.B.E. 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

Who builds on its devices?

Later devices cite its devices 3 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.

  • K980852Gii Spinal Fixation SystemKaren E. Warden, M.E.B.E. · 19983cite it

What has FDA decided for it lately?

  • K980852Gii Spinal Fixation SystemKaren E. Warden, M.E.B.E. · 1998

The one decision as Karen E. Warden, M.E.B.E. →

Other applicant names beginning “Karen”

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

Karen Holtz 1