Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K081849 |
Device Name |
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
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 | 06/30/2008 |
Decision Date | 08/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|