FDA 510(k) Application Details - K053336

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K053336
Device Name	Cement, Bone, Vertebroplasty
Applicant	SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	RONALD K SMITH 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	12/01/2005
Decision Date	07/03/2006
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