FDA 510(k) Application Details - K093419

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K093419
Device Name	Cement, Bone, Vertebroplasty
Applicant	STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	BECKY E DITTY Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2009
Decision Date	03/18/2010
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