510(k) Report

FDA applicant

Standard Surgical

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Standard Surgical (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code HTW (Bit, Drill). 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 Standard Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Standard Surgical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Standard”

FDA records each applicant name separately; these may or may not be the same firm.