FDA 510(k) Application Details - K042079

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K042079
Device Name	Screw, Fixation, Bone
Applicant	O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH 1327 7TH AVENUE HUNTINGTON, WV 25701 US Other 510(k) Applications for this Company
Contact	H. DARREL DARBY II 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	08/02/2004
Decision Date	12/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review