FDA 510(k) Application Details - K241357

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K241357
Device Name	Pin, Fixation, Threaded
Applicant	Biodynamik, Inc. 11 Orchard Road Suite 107 Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	Johnny Chen Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2024
Decision Date	01/22/2025
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