FDA 510(k) Application Details - K082282

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K082282
Device Name	Screw, Fixation, Bone
Applicant	DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	KRISTINE CHRISTO 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	08/11/2008
Decision Date	11/07/2008
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