FDA 510(k) Application Details - K150649

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K150649
Device Name	Plate, Fixation, Bone
Applicant	GENESIS FRACTURE CARE, INC. 13568 SE 97th Ave. Suite 202 Clackamas, OR 97015 US Other 510(k) Applications for this Company
Contact	MICHAEL BOTTLANG, 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	03/12/2015
Decision Date	04/30/2015
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