FDA 510(k) Application Details - K240461

Device Classification Name	More FDA Info for this Device
510(K) Number	K240461
Device Name	OsteoSinter« EVANS and COTTON wedges and related accessories
Applicant	Ames Medical Prosthetic Solutions, S.A.U. Ctra. Laurea Miro 388 Sant Feliu de Llobregat 08980 ES Other 510(k) Applications for this Company
Contact	Emili Tarrats Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2024
Decision Date	12/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review