Benefix™ Interspinous Fixation System

Dénomination commerciale

Benefix™ Interspinous Fixation System

08800015920452

B-08800015920452

Numéro de référence/catalogue

IS21638R

GS1

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 16mm
• 16mm
• 38mm

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P09070399IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• "WARNINGS AND PRECAUTIONS * Implants and instruments are provided non-sterile. Implants must be sterilized before use. Instruments must be cleaned and sterilized before use * Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. * This system is intended to be used to augment the development of a spinal fusion by providing temporary stabilization. * Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use. Use of this product without a bone graft, or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, and/or breakage of the device(s) will occur. * Preoperative and operating procedures including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of this device by the surgeon. Furthermore, the proper selection and compliance of the patient will greatly affect the results. * Surgical Technique manual can be obtained by contacting CG MedTech Co., Ltd.. * Patients who smoke have been shown to have an increased incidence of non-union. * When to use this device to diabetics, surgeon should pay attention and must inform the related risks to the patient."

  AUTRE

• "* Products intended for single-use must not be re-used. Re-use may compromise the structural integrity of the device and/or lead to device failure which may result in patient infection or disease. Furthermore, reuse of single-use devices may create a risk of contamination e.g. due to the transmission of infectious material from one patient to another. This could result in infection or disease of the patient or user. Contaminated implants must not be reprocessed. Any CG MedTech Co., Ltd. implant that has been contaminated by blood, tissue, and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol. Even though they may appear undamaged, the implants may have small defects and internal stress patterns that may cause material fatigue. * Only products within the shelf-life shall be used, and it is prohibited to re-clean and re-sterilize if the product packaging is open. * Do not use the implant if the packaging is damaged before use."