510(k) Report

FDA applicant

Sig Medical Corp.

Hershey, PA2 decisions2018–20190 recalls

FDA records 2 decisions for Sig Medical Corp. (Hershey, PA) from 2018 to 2019: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sig Medical Corporation”.

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 Sig Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Sig Medical Corp. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sig Medical Corp.’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

Which product codes does it file in?

  • HRSPlate, Fixation, Bone2decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183317AdvantageRib SystemSig Medical Corporation · 20191cites it

What has FDA decided for it lately?

  • K183317AdvantageRib SystemSig Medical Corporation · 2019
  • K182179AdvantageRib Anterior SystemSig Medical Corp. · 2018

The one decision as Sig Medical Corp. →The one decision as Sig Medical Corporation →