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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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Applicant
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510(K)
Number
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Decision
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modification to steathstation treatment guidance platform MEDTRONIC SURGICAL NAVIGATION k001153 05/03/2000
modification to synthes (usa) trochanter stabilization plate (tsb) for dhs (line extension) SYNTHES (USA) k002710 09/29/2000
modification to tissuelink bipolar forceps TISSUELINK MEDICAL, INC. k010661 05/03/2001
modification to tissuelink monopolar floating ball TISSUELINK MEDICAL, INC. k010662 04/27/2001
modification to tsrh spinal system MEDTRONIC SOFAMOR DANEK, INC. k011067 05/04/2001
modification to: erbe apc connector hose and probes, models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 ERBE USA, INC. k013348 10/26/2001
modified hydrophilic coated guidewire LAKE REGION MFG., INC. k000011 03/01/2000
modified uss fracture system SYNTHES (USA) k010658 06/04/2001
monarch ii iol delivery system ALCON RESEARCH, LTD. k001157 06/27/2000
monarch ii iol delivery system ALCON RESEARCH, LTD. k003768 01/05/2001

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