510(k) Report

FDA applicant

Swiss Orthopedic Solutions, Inc.

Downington, PA1 decision2003–20030 recalls

FDA records 1 decision for Swiss Orthopedic Solutions, Inc. (Downington, PA) in 2003: 1 510(k) clearance. All are in product code HRS (Plate, Fixation, Bone). 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 Swiss Orthopedic Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Swiss Orthopedic Solutions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision

What has FDA decided for it lately?

  • K031609Swiss Orthopedic Solutions, Inc., Small Fragment Locking Plate SystemSwiss Orthopedic Solutions, Inc. · 2003

The one decision as Swiss Orthopedic Solutions, Inc. →

Other applicant names beginning “Swiss”

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

Swiss American Metal Craft Corp. 4Swiss American Products, Inc. 4Swiss Ray Medical Systems 3Swiss Precision Mfg. Corp. 1Swiss Dental Center 1Swiss Medical Care S.A. 1