2 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
FDA Enforcement
Class I
·Terminated·Stryker Howmedica Osteonics Corp.·April 24, 2013
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
FDA Enforcement
Class I
·Ongoing·Medtronic Navigation, Inc.·November 15, 2023