Alignment socket adapter PFA02

Dénomination commerciale

Alignment socket adapter PFA02

04820304200588

482030420PFA02WJ

Numéro de référence/catalogue

Alignment socket adapter PFA02

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The PFA02 marking socket adapter is intended for mounting the PANTHER prosthetic foot for strength sports. The device is used during prosthesis fabrication to determine and mark the positions of the technological holes in the residual-limb socket and the prosthetic foot, as well as to determine the required trimming height of the prosthetic foot according to the amputation level and the structural characteristics of the prosthesis. The device is intended exclusively for external lower-limb prosthetic applications.

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.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

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

• The PFA02 is a marking and fabrication aid only and must not be used as a permanent load-bearing component of the finished prosthesis. It must be used only by a qualified prosthetist and exclusively with the compatible PANTHER prosthetic foot and approved fabrication components. Incorrect positioning, marking, drilling, or determination of the trimming height may lead to improper alignment, reduced structural integrity, component damage, or unsafe prosthetic performance. Do not use the device if it is damaged, deformed, cracked, worn, or otherwise unable to ensure accurate positioning. The device must not be modified or used for any purpose other than the fabrication and alignment of a lower-limb prosthesis.

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