FDA 510(k) Application Details - K242348

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K242348
Device Name	Screw, Fixation, Bone
Applicant	Double Medical Technology Inc. No.18, Shanbianhong East Road, Haicang District Xiamen 361026 CN Other 510(k) Applications for this Company
Contact	Joy Zuo 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	08/08/2024
Decision Date	12/04/2024
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