FDA applicant

Sofamor Danek USA,Inc.

Memphis, TN42 decisions1995–20002 recalls

FDA records 42 decisions for Sofamor Danek USA,Inc. (Memphis, TN) from 1995 to 2000: 42 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). 2 recalls are linked to its devices.

FDA’s records also spell it “Sofamor Danek USA”.

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 Sofamor Danek USA,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sofamor Danek USA,Inc. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Sofamor”

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

Sofamor Danek Mfg., Inc. 23 Sofamor Co. 5 Sofamor Danek 2

Sofamor Danek USA,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 “Sofamor”