FDA applicant

Integra Neurosciences Implants S.A.

Planisboro, NJ6 decisions2003–20082 recalls

FDA records 6 decisions for Integra Neurosciences Implants S.A. (Planisboro, NJ) from 2003 to 2008: 6 510(k) clearances. All are in product code JXG (Shunt, Central Nervous System And Components). Its devices cite 8 predicates, 1 of them its own earlier devices. 2 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, neurology panel, where it files most

How often FDA has decided Integra Neurosciences Implants S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Integra Neurosciences Implants S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Integra Neurosciences Implants S.A.’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 “Integra”

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

Integra LifeSciences Corporation 101 Integra Neurocare, LLC 12 Integra Radionics, Inc. 10 Integra Neurosciences 9 Integra Lifesciences Production Corporation 9 Integra Life Sciences 3 Integra Medical 2 Integra Lifescience Corportation 2 Integra Lifesciences Corporation (Owner of Tei… 1 Integra Microfrance 1 Integra Biotechnical, LLC 1 Integra Burlington Ma, Inc. 1

Integra Neurosciences Implants S.A.

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 “Integra”