Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K041939 |
Device Name |
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS |
Applicant |
BLACKSTONE MEDICAL, INC. |
90 BROOKDALE DR. |
SPRINGFIELD,
MA
01104
|
|
Applicant Contact |
DEAN E CIPORKIN |
Correspondent |
BLACKSTONE MEDICAL, INC. |
90 BROOKDALE DR. |
SPRINGFIELD,
MA
01104
|
|
Correspondent Contact |
DEAN E CIPORKIN |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 07/19/2004 |
Decision Date | 08/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|