FDA 510(k) Application Details - K242216

Device Classification Name	Bone Cement, Antibiotic   More FDA Info for this Device
510(K) Number	K242216
Device Name	Bone Cement, Antibiotic
Applicant	Teknimed SAS 11-12 Rue d'Apollo L'Union 31240 FR Other 510(k) Applications for this Company
Contact	Claudine Lavergne Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	MBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2024
Decision Date	12/18/2024
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