FDA applicant

The Jerome Group, Inc.

Moorestown, NJ2 decisions2003–20047 recalls

FDA records 2 decisions for The Jerome Group, Inc. (Moorestown, NJ) from 2003 to 2004: 2 510(k) clearances. Most are in product codes LYT (Fixation Accessory) and HAX (Tong, Skull For Traction). Its devices cite 3 predicates, 0 of them its own earlier devices. 7 recalls are 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 The Jerome Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Jerome Group, Inc. since 2007.

Recalls per year

1in 2018

2007high 6 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like The Jerome Group, Inc.’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 “The”

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

Jerome Medical 9 Jerome Instrument Corp. 1 Jerome M. Simon 1

The Jerome Group, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “The”