FDA 510(k) Application Details - K243477

Device Classification Name	Prosthesis, Tendon, Passive   More FDA Info for this Device
510(K) Number	K243477
Device Name	Prosthesis, Tendon, Passive
Applicant	Askorn Medical 44c rue de Bray Cesson-SΘvignΘ 35510 FR Other 510(k) Applications for this Company
Contact	Denis Pichon Other 510(k) Applications for this Contact
Regulation Number	888.3025   More FDA Info for this Regulation Number
Classification Product Code	HXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2024
Decision Date	01/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review