ARTHROVIMS ANCHOR LRP

Dénomination commerciale

ARTHROVIMS ANCHOR LRP

18904210319886

B-18904210319886

Numéro de référence/catalogue

VIMS-9092.55F

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

ArthroVIMS ANCHOR LRP Ligament Anchor, PEEK Knotless, Dia. 5.5mm

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• P09120102ANCHORS, TENDON AND LIGAMENT SYNTHESIS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  Foreign body sensitivity or Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to Acute or chronic local or systemic infection. implantation. Patient conditions including Blood supply limitation and previous infections which may tend to retard healing. Insufficient quantity or quality of bone or soft tissue. Anchor performance is directly related to the quality of bone or soft tissue into which the anchor is placed. Pathological conditions of bone & soft tissue, such as cystic changes, tumor or severe osteopenia, which would compromise secure implant fixation. Comminuted bone surface, which would compromise secure implant fixation. Severe muscular, nervous, and/or vascular disorders that could endanger the limb. Any concomitant illness and/or dependence that could risk implanting function. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow the surgeon's prescribed post-operative regimen during the healing period. Any situation that would compromise the ability of the user to follow the instructions for use or using the device for an indication other than those listed. Excessive body activities that could cause overloading of the implant.