FDA 510(k) Application Details - K103816

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K103816
Device Name	Cement, Bone, Vertebroplasty
Applicant	TEKNIMED, S.A.S. 1001 OAKWOOD BLVD ROUND ROCK, TX 78681 US Other 510(k) Applications for this Company
Contact	J. D WEBB 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	12/29/2010
Decision Date	02/04/2011
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