You want to consult the instructions for a NORAKER device that has been or will soon be implanted to you?
We make all of our notices available to you.
Summary of Safety and Clinical Performance (SSCP)
PUTTY
(GlassBone-IP, AktiBone-IP, BiologicGlass-IP, MectaGlass-IP)
GRANULES
(GlassBone-G, AktiBone-G, BiologicGlass-G, MectaGlass-G)
PATIENT LEAFLET
Implant card
Graft card
Following your surgery, an implant card was sent to you by your surgeon. Its role is to inform you about the product you have received and to ensure full traceability. If you want to know the meaning of the different pictograms used, we provide you with our model implant card.
RCSPC
The Summary of Safety Characteristics and Clinical Performance (RCSPC) is a new European requirement for implantable and most risky medical devices.
The RCSPC is a document approved as part of the marketing authorization for each medical device. We make it available to patients or future patients, but it can also be downloaded via the Eudamed database (as soon as it is available). This summary is a complete overview of the device and its intended use. It also lists the associated risks and the precautions for use. The Summary of Safety Characteristics and Clinical Performance presents the available clinical data and also those being acquired as well as possible medical alternatives. This summary has been written in the most popularized way possible to ensure maximum understanding by all patients or future patients. However, if questions persist, we invite you to consult your surgeon.
