FDA 510(k) Application Details - K080358

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K080358
Device Name	Screw, Fixation, Bone
Applicant	SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	DEANA BOUSHELL 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	02/11/2008
Decision Date	04/23/2008
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