5 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016