510(k) Report

FDA applicant

Skeltex Technologies, Inc.

Boucherville, Quebec, CA1 decision2010–20100 recalls

FDA records 1 decision for Skeltex Technologies, Inc. (Boucherville, Quebec, CA) in 2010: 1 510(k) clearance. All are in product code NDN (Cement, Bone, Vertebroplasty). 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 Skeltex Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Skeltex Technologies, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Skeltex Technologies, 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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