FDA applicant

Plastafil, Inc.

Mchenry, IL13 decisions1984–19840 recalls

FDA records 13 decisions for Plastafil, Inc. (Mchenry, IL) in 1984: 13 510(k) clearances. Most are in product codes HWQ (Passer) and HTX (Rongeur). 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 Plastafil, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Plastafil, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Plastafil, Inc.

Which product codes does it file in?

What has FDA decided for it lately?