Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K102248 |
Device Name |
EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
Applicant |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
MARSHALL C MCCARTY |
Correspondent |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
MARSHALL C MCCARTY |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/09/2010 |
Decision Date | 10/07/2010 |
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
|
|
|