Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K081177 |
Device Name |
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM |
Applicant |
BLACKSTONE MEDICAL, INC. |
1211 HAMBURG TURNPIKE |
SUITE 300 |
WAYNE,
NJ
07470
|
|
Applicant Contact |
WHITNEY G TORNING |
Correspondent |
BLACKSTONE MEDICAL, INC. |
1211 HAMBURG TURNPIKE |
SUITE 300 |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
WHITNEY G TORNING |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/25/2008 |
Decision Date | 07/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|