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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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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


 
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General
Study Status Terminated
522 Number / Requirement Number PS090017 / PSS001
Date Original Plan Accepted 11/06/2012
Date Current Plan Accepted 11/06/2012
Study Name Fusion, AEs, Surg Procedures
Device Name Zimmer® dynesys® top-loading spinal system
Root Document Number K073347 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The manufacturer has requested to consolidate their multiple 522 orders into one. The original order has been amended to include these devices in one study that will fulfill the 522 order. This device is now included in PS090016


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report due 10/04/2011 10/04/2011 On Time
1 year report 05/30/2012 04/02/2012 On Time
18 month report 11/30/2012 10/03/2012 On Time
2 yr report 04/02/2013 04/02/2013 On Time


Contact Us

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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