FDA applicant

Sofamor Co.

France, FR5 decisions1985–19960 recalls

FDA records 5 decisions for Sofamor Co. (France, FR) from 1985 to 1996: 5 510(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 Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sofamor Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sofamor Co. 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 Danek 2

Sofamor Co.

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”