FDA 510(k) Application Details - K081813

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K081813
Device Name	Screw, Fixation, Bone
Applicant	U.S. IMPLANT SOLUTIONS, LLC 650 SOUTH CENTRAL AVENUE SUITE 1000 OVIEDO, FL 32765 US Other 510(k) Applications for this Company
Contact	SCOTT GARRETT 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	06/26/2008
Decision Date	03/12/2009
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