FDA applicant

Sofamor Danek Mfg., Inc.

Memphis, TN23 decisions1992–19950 recalls

FDA records 23 decisions for Sofamor Danek Mfg., Inc. (Memphis, TN) from 1992 to 1995: 23 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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 Sofamor Danek Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sofamor Danek Mfg., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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 Co. 5 Sofamor Danek 2

Sofamor Danek Mfg., 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?

Other applicant names beginning “Sofamor”