FDA applicant

Danek Medical, Inc.

Memphis, TN56 decisions1981–20001 recall

FDA records 56 decisions for Danek Medical, Inc. (Memphis, TN) from 1981 to 2000: 56 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and HRX (Arthroscope). 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 Danek Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Danek Medical, Inc.’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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Other applicant names beginning “Danek”

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

Danek Group, Inc. 2

Danek Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Danek”