FDA 510(k) Application Details - K133372

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K133372
Device Name	Cement, Bone, Vertebroplasty
Applicant	CROSSTREES MEDICAL, INC. 135 MARKET ST., 29TH FLOOR PHILADELPHIA, PA 19119 US Other 510(k) Applications for this Company
Contact	JANICE HOGAN 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	11/01/2013
Decision Date	12/06/2013
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