FDA applicant

Depuy Spine, A Johnson & Johnson Company

Raynham, MA4 decisions2007–20130 recalls

FDA records 4 decisions for Depuy Spine, A Johnson & Johnson Company (Raynham, MA) from 2007 to 2013: 4 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OSH (Pedicle Screw Spinal System, Adolescent…). Its devices cite 13 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 Depuy Spine, A Johnson & Johnson Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Depuy Spine, A Johnson & Johnson Company by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Depuy Spine, A Johnson & Johnson Company’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 “Depuy”

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

Depuy, Inc. 307 DePuy Orthopaedics, Inc. 213 Depuy Spine, Inc. 73 Depuy Mitek, A Johnson & Johnson Company 59 Depuy Ireland UC 50 DePuy Synthes 20 Depuy Mitek 15 Depuy (Ireland) 13 Depuy Ace Medical Co. 10 Depuy Mitek, Inc., A Johnson and Johnson Company 6 Depuy Motech Acromed 4 Depuy France S.A.S. 4

Depuy Spine, A Johnson & Johnson Company

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?

Other applicant names beginning “Depuy”