Device Classification Name |
Orthosis, Spine, Plate, Laminoplasty, Metal
More FDA Info for this Device |
510(K) Number |
K043338 |
Device Name |
Orthosis, Spine, Plate, Laminoplasty, Metal |
Applicant |
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD, MA 01104 US
Other 510(k) Applications for this Company
|
Contact |
DEAN CIPORKIN
Other 510(k) Applications for this Contact |
Regulation Number |
888.3050
More FDA Info for this Regulation Number |
Classification Product Code |
NQW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/03/2004 |
Decision Date |
02/18/2005 |
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 |
|