3 results
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10ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013