FDA 510(k) Application Details - K242271

Device Classification Name	More FDA Info for this Device
510(K) Number	K242271
Device Name	Caduceus S
Applicant	Taiwan Main Orthopaedic Biotechnology Co., Ltd. 2F., No. 41, Keya Rd., Daya Dist Taichung City 428015 TW Other 510(k) Applications for this Company
Contact	Jacky Fan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2024
Decision Date	10/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review