FDA 510(k) Application Details - K102326

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K102326
Device Name	Screw, Fixation, Bone
Applicant	PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. STURGEON BAY, WI 54235 US Other 510(k) Applications for this Company
Contact	BARION BRACY 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	08/17/2010
Decision Date	11/15/2010
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