FDA applicant

Sofamor Danek

Memphis, TN2 decisions1999–19991 recall

FDA records 2 decisions for Sofamor Danek (Memphis, TN) in 1999: 1 510(k) clearance and 1 original PMA approval. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and MAX (Intervertebral Fusion Device With Bone Graft…). 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 Sofamor Danek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sofamor Danek since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sofamor Danek 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 USA,Inc. 42 Sofamor Danek Mfg., Inc. 23 Sofamor Co. 5

Sofamor Danek

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”