Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K042100 |
Device Name |
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR |
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 | 08/04/2004 |
Decision Date | 09/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|