Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K040034 |
Device Name |
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER |
Applicant |
BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. |
SPRINGFIELD,
MA
01104
|
|
Applicant Contact |
DEAN CIPORKIN |
Correspondent |
BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. |
SPRINGFIELD,
MA
01104
|
|
Correspondent Contact |
DEAN CIPORKIN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/08/2004 |
Decision Date | 02/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|