Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K133287 |
Device Name |
PRESSON SPINAL FIXATION SYSTEM |
Applicant |
NEXUS SPINE, LLC |
2825 EAST COTTONWOOD PKWY. |
SALT LAKE CITY,
UT
84121
|
|
Applicant Contact |
CHRIS HARMSTON |
Correspondent |
NEXUS SPINE, LLC |
2825 EAST COTTONWOOD PKWY. |
SALT LAKE CITY,
UT
84121
|
|
Correspondent Contact |
CHRIS HARMSTON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/25/2013 |
Decision Date | 02/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|