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Integra Burlington Ma, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Integra Burlington Ma, Inc. makes

Integra Burlington MA, Inc. manufactures surgical instruments, including the INTEGRA CUSA NXT Inferior Forward Bone Tip, a device used in ultrasonic aspiration systems for neurosurgical and spinal procedures to remove tissue and bone.

This product is classified as Class II (U) under FDA regulations and is listed in the FDA 510(k) database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Integra Burlington Ma, Inc., initiated on 2013-03-18. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2013

    • 18 Mar 2013 Z-1030-2013 Class II Terminated If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury. Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain,…
      Full distribution text Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.
      Submission number: K924226

Frequently asked questions

How many devices does Integra Burlington Ma, Inc. have in the registry?

The registry currently lists 1 device for Integra Burlington Ma, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Integra Burlington Ma, Inc.'s devices?

Among its 1 most recently registered device, Integra Burlington Ma, Inc. has devices listed in FDA 510(k) (1 device).

Are there FDA recall records for Integra Burlington Ma, Inc.?

FDA recall records list 1 recall initiated by Integra Burlington Ma, Inc., the most recent initiated on 18 Mar 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Integra Burlington Ma, Inc. in the registry?

The most recently registered devices listed for Integra Burlington Ma, Inc. include INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP.

Generated automatically from registry data and not verified by a human reviewer.