510(k) Report

FDA applicant

Danek Group, Inc.

Memphis, TN2 decisions1994–19950 recalls

FDA records 2 decisions for Danek Group, Inc. (Memphis, TN) from 1994 to 1995: 2 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and 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 Danek Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Danek Group, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Danek Group, 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?

  • KWPAppliance, Fixation, Spinal Interlaminal1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

What has FDA decided for it lately?

  • K936307Dyna-Lok Anterior Plating SystemDanek Group, Inc. · 1995
  • K934582GDLH Variable Angle ConnectorDanek Group, Inc. · 1994

All 2 as Danek Group, Inc. →

Other applicant names beginning “Danek”

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

Danek Medical, Inc. 56