FDA 510(k) Application Details - K233008

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K233008
Device Name	Screw, Fixation, Bone
Applicant	aap Implantate AG Lorenzweg 5 Berlin 12099 DE Other 510(k) Applications for this Company
Contact	Agnieszka Mierzejewska Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2023
Decision Date	06/05/2024
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