522 Postmarket Surveillance Studies Database

The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Fusion, AEs, Surg Procedures

General
Study Status	Terminated
522 Number / Requirement Number	PS090012 / PSS001
Date Original Plan Accepted	10/05/2009
Study Name	Fusion, AEs, Surg Procedures
Device Name	Isobar semi-rigid spinal system & dual dampener
Root Document Number	K991326  K071261
General Study Protocol Parameters
Study Design	Randomized Clinical Trial
Data Source	New Data Collection
Comparison Group	Concurrent Control
Analysis Type	Analytical
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The manufacturer ceased market distribution of the device subject to the postmarket surveillance order. If manufacturer resumes device distribution they will be required to address the postmarket surveillance order.

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry and Food and Drug Administration Staff
• 522 Program Background