FDA 510(k) Application Details - K192768

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K192768
Device Name	Pin, Fixation, Threaded
Applicant	EiserTech, LLC 9988 Hibert Street Suite 302 San Diego, CA 32131 US Other 510(k) Applications for this Company
Contact	Lukas Eisermann 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	09/30/2019
Decision Date	12/26/2019
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