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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
Date
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modification to cavermap surgical aid Uromed Corp. k010098 02/01/2001
modification to iskd (intramedullary skeletal kinetic distractor) Orthofix, Inc. k031219 05/28/2003
modification to isobar spinal system Encore Orthopedics, Inc. k000020 02/03/2000
modification to onyx, finger clip pulse oximeter, model 9500 Nonin Medical, Inc. k001085 05/01/2000
modification to provident hip system Stelkast Company k001745 07/27/2000
modification to tsrh spinal system Medtronic Sofamor Danek, Inc. k011029 06/05/2001
modification to: dss stabilization system Paradigm Spine, LLC k091944 08/03/2009
modified chick ambulatory halo Chick Medical Products k884242 12/29/1988
modified peripheral dilatation catheters Schneider-Shilley (Usa) k875175 07/28/1988
modified smec percutaneous intra-aortic Smec, Inc. k840037 02/01/1985

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