Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K093926 |
Device Name |
FIREBIRD SPINAL FIXATION SYSTEM |
Applicant |
BLACKSTONE MEDICAL, INC. |
1211 HAMBURG TURNPIKE |
SUITE 300 |
WAYNE,
NJ
07470
|
|
Applicant Contact |
RUSSELL JOHNSON |
Correspondent |
BLACKSTONE MEDICAL, INC. |
1211 HAMBURG TURNPIKE |
SUITE 300 |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
RUSSELL JOHNSON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/22/2009 |
Decision Date | 07/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|