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188宝金博页面版: PREMARKET NOTIFICATION 510(K) SUBMISSION …

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内容提示: PREMARKET NOTIFICATION 510(K) SUBMISSION Page 6 of 45ROSA SURGICAL DEVICE5 -51(K) SUMMAY[As Required by 21 CFR 807.92]Summary of Safety and Effectiveness 1I Submitter MedTech S.AParc Eurom~decine B5timent 8 SEP 2 3 20101006 rue de la Croix Verte34090 MontpellierFranceContact Person Bertin NAHUM, PresidentPhone number: (+33) 467 107 740Fax number: (+33) 467 597 418Preparation date June 10, 2010Revision date July 20, 2010Revision date August 18, 2010Revision date September 02, 20102 Device nameTrade Name ROS...

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PREMARKET NOTIFICATION 510(K) SUBMISSION Page 6 of 45ROSA SURGICAL DEVICE5 -51(K) SUMMAY[As Required by 21 CFR 807.92]Summary of Safety and Effectiveness 1I Submitter MedTech S.AParc Eurom~decine B5timent 8 SEP 2 3 20101006 rue de la Croix Verte34090 MontpellierFranceContact Person Bertin NAHUM, PresidentPhone number: (+33) 467 107 740Fax number: (+33) 467 597 418Preparation date June 10, 2010Revision date July 20, 2010Revision date August 18, 2010Revision date September 02, 20102 Device nameTrade Name ROSA Surgical DeviceCommon Name Computer-assisted surgical deviceCode product and Stereotaxic Instrument (HAW), 21 CFR Section 882.4560classification name3 Predicate devices ROSA Surgical Device, manufactured by MedTech SAS,K092239, cleared November 17, 2009StealthStation Treatment Guidance Platform, manufactured byMedtronic Surgical Navigation Technologies, K001801, clearedJune 30, 2000VectorVision Cranial / ENT, manufactured by BrainLAB AG,K023651, cleared February 17, 2004Frameless Neuromate Stereotactic System, manufactured byIntegrated Surgical Systems, Inc., K991081, cleared June 25,19994 Description ROSA Surgical Device is a computer controlledelectromechanical arm. It is intended to be used in theoperating room for the spatial positioning and orientation of aninstrument holder or tool guide.Guidance is based on a pre-operative plan developed withthree-dimensional imaging software, and uses fiducial markersor optical registration.The system is intended for use by neurosurgeons to guide-standard neurosurgical instruments.

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