FDA 510(k) Application Details - K181067

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K181067
Device Name	Plate, Fixation, Bone
Applicant	Extremity Medical, LLC 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Brian Smekal Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2018
Decision Date	05/23/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review