Device Classification Name |
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
More FDA Info for this Device |
510(K) Number |
K063606 |
Device Name |
Cement, Bone, Pre-Formed, Modular, Polymeric, 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 |
OBL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/01/2006 |
Decision Date |
04/13/2007 |
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 |
|