510(k) Report

FDA applicant

Integra Lifescience Corportation

Planisboro, NJ2 decisions2012–20140 recalls

FDA records 2 decisions for Integra Lifescience Corportation (Planisboro, NJ) from 2012 to 2014: 2 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and GWM (Device, Monitoring, Intracranial Pressure). Its devices cite 5 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 Integra Lifescience Corportation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012: 12014: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Integra Lifescience Corportation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound1decision
  • GWMDevice, Monitoring, Intracranial Pressure1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex AdapterIntegra Lifescience Corportation · 20122cite it

What has FDA decided for it lately?

  • K141841Integra Mozaik Osteoconductive Scaffold - StripIntegra Lifescience Corportation · 2014
  • K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex AdapterIntegra Lifescience Corportation · 2012

All 2 as Integra Lifescience Corportation →

Other applicant names beginning “Integra”

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

Integra LifeSciences Corporation 101Integra Neurocare, LLC 12Integra Radionics, Inc. 10Integra Neurosciences 9Integra Lifesciences Production Corporation 9Integra Neurosciences Implants S.A. 6Integra Life Sciences 3Integra Medical 2Integra Lifesciences Corporation (Owner of Tei… 1Integra Microfrance 1Integra Biotechnical, LLC 1Integra Burlington Ma, Inc. 1