510(k) Report

FDA applicant

Sterilemed, Inc.

Maple Grove, MN1 decision2005–20051 recall

FDA records 1 decision for Sterilemed, Inc. (Maple Grove, MN) in 2005: 1 510(k) clearance. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Sterilemed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterilemed, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sterilemed, 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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Which product codes does it file in?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K051957Reprocessed External Fixation DeviceSterilemed, Inc. · 20051 recall

The one decision as Sterilemed, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051957External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84…Aug 8, 2008