FDA 510(k) Application Details - K180024

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K180024
Device Name	Screw, Fixation, Bone
Applicant	Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 US Other 510(k) Applications for this Company
Contact	Alayne Melancon 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	01/03/2018
Decision Date	07/11/2018
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