FDA 510(k) Application Details - K151021

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K151021
Device Name	Screw, Fixation, Bone
Applicant	OSTEOMED CORP. 3885 Arapho Road Addison, TX 75001 US Other 510(k) Applications for this Company
Contact	Blesson Abraham 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	04/16/2015
Decision Date	07/15/2015
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