FDA applicant

Sign Fracture Care International

Richland, WA4 decisions2013–20170 recalls

FDA records 4 decisions for Sign Fracture Care International (Richland, WA) from 2013 to 2017: 4 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HWC (Screw, Fixation, Bone). Its devices cite 11 predicates, 0 of them its own earlier devices. 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 Sign Fracture Care International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Sign Fracture Care International by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sign Fracture Care International’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Sign”

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

Sign, Inc. 1

Sign Fracture Care International

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sign”