Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K162143 |
Device Name |
FixxSure® X-Link |
Applicant |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
MARSHALL MCCARTY |
Correspondent |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
MARSHALL MCCARTY |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2016 |
Decision Date | 09/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|