FDA 510(k) Application Details - K063478

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K063478
Device Name	Screw, Fixation, Bone
Applicant	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	RUTH C FOSTADT 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	11/17/2006
Decision Date	12/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review