FDA 510(k) Application Details - K050388

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K050388
Device Name	Screw, Fixation, Bone
Applicant	XTREMI-T, LLC 3131 PRINCETON PIKE, BLDG. 5 SUITE 200 LAWRENCEVILLE, NJ 08648 US Other 510(k) Applications for this Company
Contact	SHAWAN T HUXEL 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	02/15/2005
Decision Date	09/07/2005
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